RESUMEN
INTRODUCTION: surgical pain is managed with multi-modal anesthesia in total knee arthroplasty (TKA). It is dubious whether including local infiltrative anaesthesia (LIA) before wound closure provides adequate pain control and decreases morbidity. MATERIAL AND METHODS: this was a retrospective conducted to assess postoperative pain control, morbidity index, and opioid consumption in 116 patients who underwent TKA and were divided into two groups based on LIA (Modified Ranawat Regimen) or normal saline infiltration in the wound. RESULTS: the mean NRS score was significantly lower in LIA group (3.2) as compared to the control group (3.9) in the first 24 hours. Functional milestones were relatively achieved earlier in LIA group but the values were not significant. Tramadol consumption was remarkably higher in the control group as compared to LIA group on day 1 and 2. As per the morbidity index the mean score on day one was 16.18 and 23.40 which decreased to 6.37 and 9.21 by day three in LIA and control group respectively indicating morbidity has decreased but more so in LIA group. CONCLUSION: our study concludes that use of modified cocktail regimen in the knee effectively decreased morbidity with excellent to good results, declining NRS score, minimal rescue analgesia requirement, early ambulation with better safety.
INTRODUCCIÓN: el dolor quirúrgico se trata con anestesia multimodal en la artroplastia total de rodilla (ATR). Es dudoso que incluir anestesia local infiltrativa (LIA) antes del cierre de la herida proporcione un control adecuado del dolor y disminuya la morbilidad. MATERIAL Y MÉTODOS: se realizó una retrospectiva para evaluar el control del dolor posoperatorio, el índice de morbilidad y el consumo de opioides en 116 pacientes sometidos a ATR y se dividieron en dos grupos según el LIA (régimen de Ranawat modificado) o la infiltración de solución salina normal en la herida. RESULTADOS: la puntuación media NRS fue significativamente menor en el grupo LIA (3.2) en comparación con el grupo control (3.9) en las primeras 24 horas. Los hitos funcionales se alcanzaron relativamente antes en el grupo LIA, pero los valores no fueron significativos. El consumo de tramadol fue notablemente mayor en el grupo de control en comparación con el grupo de LIA los días 1 y 2. Según el índice de morbilidad, la puntuación media el día uno fue 16.18 y 23.40, que disminuyó a 6.37 y 9.21 en el día tres en el grupo de LIA y control, respectivamente, lo que indica que la morbilidad ha disminuido, pero más en el grupo LIA. CONCLUSIÓN: nuestro estudio concluye que el uso de un régimen de cóctel modificado en la rodilla disminuyó efectivamente la morbilidad con resultados excelentes a buenos, una disminución de la puntuación NRS, un requisito mínimo de analgesia de rescate y una deambulación temprana con mayor seguridad.
Asunto(s)
Anestésicos Locales , Artroplastia de Reemplazo de Rodilla , Dolor Postoperatorio , Humanos , Estudios Retrospectivos , Artroplastia de Reemplazo de Rodilla/métodos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Femenino , Masculino , Persona de Mediana Edad , Anciano , Anestésicos Locales/administración & dosificación , Anestésicos Locales/uso terapéutico , Centros de Atención Terciaria , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Anestesia Local/métodos , Resultado del Tratamiento , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Dimensión del DolorRESUMEN
OBJECTIVE: Evaluation of the analgesic, opioid-sparing, anti-inflammatory and adverse effects of the diclofenac and orphenadrine (Neodolpasse) fixed combination for analgesia in the postoperative period of surgical cancer patients. MATERIAL AND METHODS: A randomized, single-center, prospective, comparative study evaluated two analgesic regimens in 40 cancer patients undergoing various open cavity surgeries, including extensive combined interventions associated with the resection of 3 or more organs. The study was conducted following the transfer from the ICU to the surgical department during the early activation period, within the first two postoperative days. In the first group N (n=20), "Neodolpasse" (a fixed combination of 75 mg Diclofenac and 30 mg Orphenadrine) was administered as an infusion, twice daily. In the second group K (n=20) analgesia was performed with ketoprofen as an intravenous infusion at a daily dose of 200 mg. Patients in both groups received scheduled prolonged epidural analgesia with 0.2% ropivacaine, and when the severity of pain in a visual analogue scale (VAS) increased to more than 40 mm, so an additional dose of 100 mg tramadol was administered intramuscularly. Daily measurments of blood creatinine level and C-reactive protein were taken, postoperative blood loss was accounted for, as well as postoperative complications according to the Clavien-Dindo classification. RESULTS: The comparative analysis of the indicators of pain syndrome severity showed that the patients in group N exhibited a more pronounced analgesic effect, so on the second postoperative day 30% of patients reported moderate pain (from 50 to 60 mm on the pain scale), on the third day - 15%, and by the fourth day - all 100% of patients experienced pain of low intensity. The additional analgesia with tramadol in group N was required twice less than in the comparison group, and such adverse effects as nausea, drowsiness, and weakness were significantly more common in the ketoprofen group. In both groups, the average blood creatinine level did not exceed permissible values, and the C-reactive protein was elevated at all stages of the study but tended to decrease by the fourth day. The analysis of postoperative complications according to the Clavien-Dindo scale at the time of discharge did not reveal a direct correlation between the occurred complications and the use of NSAIDs. Adverse effects such as anastomotic failure, gastrointestinal complications, or other hemorrhagic manifestations were not recorded. CONCLUSION: The inclusion of Neodolpasse into multimodal analgesic regimens resulted in the most pronounced analgesic and opioid-sparing effects in surgical cancer patients using laparotomy access. Additionally, the application of short courses of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with a favorable safety profile.
Asunto(s)
Diclofenaco , Orfenadrina , Dimensión del Dolor , Dolor Postoperatorio , Humanos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Masculino , Femenino , Persona de Mediana Edad , Diclofenaco/administración & dosificación , Orfenadrina/administración & dosificación , Orfenadrina/efectos adversos , Antiinflamatorios no Esteroideos/administración & dosificación , Antiinflamatorios no Esteroideos/uso terapéutico , Resultado del Tratamiento , Combinación de Medicamentos , Manejo del Dolor/métodos , Neoplasias Abdominales/cirugía , Estudios Prospectivos , Anciano , Tramadol/administración & dosificación , Tramadol/efectos adversos , Adulto , Analgésicos Opioides/administración & dosificaciónRESUMEN
INTRODUCTION: Proximal femur fractures are common among older individuals and pose challenges in achieving effective post-operative analgesia. Age-related co-morbidities limit the selection of analgesics in this population. This study aimed to compare the safety and effectiveness of transdermal buprenorphine (TDB) patch with traditional analgesics after fixation of an extracapsular fracture of the proximal femur. METHODOLOGY: A prospective randomized controlled study was conducted over a 2-year period, involving 60 patients who underwent surgery for extra capsular intertrochanteric fracture fixation. The patients were randomly assigned to two groups by random envelope method. Group A received an intravenous formulation of paracetamol and tramadol for the initial 48 h, followed by an oral formulation. Group B received a transdermal buprenorphine (TDB) patch delivering 5 mcg/hour immediately after surgery, which continued for 2 weeks postoperatively. During the 14-day monitoring period, patients' pain scores were assessed using the Visual Analog Scale (VAS) at rest and during movement. The primary objective was to maintain a VAS score of 4 or lower. Rescue analgesics were administered if the VAS score reached 6. The secondary objectives included evaluating the quantity of rescue analgesics required and monitoring for any adverse effects or complications. RESULTS: Pain scores at rest and during movement were significantly lower in Group B at all-time points (p-value 0.0006 - ≤ 0.0001), and the requirement for rescue analgesia was also significantly lower in this group. The administration of the TDB patch did not result in any significant adverse effects. CONCLUSION: TDB patch is secure and offers better compliance and analgesia than other analgesics in the postoperative period whilst treating proximal femur extra capsular fracture.
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Analgésicos Opioides , Buprenorfina , Dimensión del Dolor , Dolor Postoperatorio , Parche Transdérmico , Humanos , Femenino , Masculino , Dolor Postoperatorio/tratamiento farmacológico , Buprenorfina/administración & dosificación , Estudios Prospectivos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Resultado del Tratamiento , Anciano , Persona de Mediana Edad , Acetaminofén/administración & dosificación , Acetaminofén/uso terapéutico , Administración Cutánea , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Fracturas de Cadera/cirugía , Manejo del Dolor/métodosRESUMEN
OBJECTIVE: To investigate the effects of pregabalin combined with tramadol/paracetamol on acute pain in patients with CT-guided puncture localization of pulmonary nodules. MATERIALS AND METHODS: In this randomized, placebo-controlled and single-center study, 120 patients were allocated randomly to four groups: the control group (Group P), the pregabalin-placebo group (Group BP), the tramadol/paracetamol-placebo group (Group AP), and the pregabalin-tramadol/paracetamol group (Group AB). The primary outcome was the NRS (Numerical Rating Scale) score. Other outcomes included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), pulse oxygen saturation (SpO2), the incidence of moderate to severe pain, the analgesia recovery ratio, the incidence of adverse drug reactions and patients' satisfaction. RESULTS: No significant interaction was detected between the interventions (P = 0.752). The NRS score of the Taking pregabalin group and the Taking tramadol/paracetamol group were significantly lower than those of the Not-taking pregabalin group and the Not-taking tramadol/paracetamol group respectively (P < 0.05). There was significant difference in the NRS scores among the four groups (P < 0.001). The NRS score of Group AB was significantly lower than that of Group P (P < 0.001), Group BP (P < 0.001) and Group AP (P = 0.001). At the same time, the NRS scores of Group BP (P < 0.001) and Group AP (P < 0.001) were significantly lower than those of Group P, but there was no significant difference between Group BP and Group AP (P = 1.000). The SBP, DBP, HR, the incidence of moderate to severe pain and the analgesia recovery ratio of Group AB were significantly lower than those of Group P (P < 0.05), while the SpO2 and the number of people who were very satisfied were significantly higher than those of Group P (P < 0.05). There was no significant difference in the incidence of adverse drug reactions among the four groups (P = 0.272). CONCLUSIONS: The combination or single use of pregabalin and tramadol/paracetamol can effectively relieve the acute pain after localization. Pregabalin combined with tramadol/paracetamol has the best analgesic effect and significantly reduces the hemodynamic fluctuations, with high safety and low incidence of adverse drug reactions, which has a certain clinical popularization and application value.
Asunto(s)
Acetaminofén , Dolor Agudo , Pregabalina , Tomografía Computarizada por Rayos X , Tramadol , Humanos , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Tramadol/efectos adversos , Pregabalina/uso terapéutico , Pregabalina/administración & dosificación , Pregabalina/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Acetaminofén/administración & dosificación , Acetaminofén/uso terapéutico , Acetaminofén/efectos adversos , Dolor Agudo/tratamiento farmacológico , Dolor Agudo/etiología , Dolor Agudo/diagnóstico , Tomografía Computarizada por Rayos X/métodos , Anciano , Quimioterapia Combinada , Adulto , Neoplasias Pulmonares/tratamiento farmacológico , Analgésicos/administración & dosificación , Analgésicos/uso terapéutico , Analgésicos/efectos adversos , Punciones/efectos adversos , Punciones/métodos , Resultado del Tratamiento , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Analgésicos Opioides/uso terapéutico , Manejo del Dolor/métodos , Nódulo Pulmonar Solitario/diagnóstico por imagen , Nódulo Pulmonar Solitario/tratamiento farmacológico , Nódulo Pulmonar Solitario/patología , Dimensión del DolorRESUMEN
Background: This non-randomized study aimed to compare the efficacy of two pharmacological treatments, "around-the-clock" analgesic treatment (ACAT) and "on-demand" analgesic treatment (ODAT), for managing postoperative pain following hemorrhoidectomy. Material and Methods: The study, conducted from July 2016 to December 2020, included 5335 hemorrhoidectomy patients. Participants were divided into ACAT (3767) and ODAT (1568) groups. The study was registered at clinicaltrials.gov (NCT04953182). Results: Patients had a mean age of 47.47 years, with 59.98% males. Postoperatively, 14.13% reported severe pain, 36.49% moderate, 34.28% mild, and 15.09% no pain. ACAT group's maximum pain was 3.04 (VAS), ODAT 4.95 (p; average pain was 0.79 (ACAT) and 1.45 (ODAT). Discharge pain was 0.42 (ACAT) and 0.63 (ODAT) VAS. The ACAT group consistently reported lower levels of pain across all measured instances. Higher BMI and younger age were pain risk factors (p=.049, p .001 respectively). ACAT administration resulted in reduced opioid usage, with meperidine showing a 68.38% decrease, morphine 43.57% less, tramadol 46.82% less, oxycodone reduced by 38.74%, and codeine by 53.40%. Additionally, the use of non-opioid analgesics was notably lower in the ACAT group, ranging from 16% to 59% less compared to the ODAT group. Conclusion: Hemorrhoidectomy induces moderate postoperative pain, with only 14% experiencing severe pain. A fixed schedule multimodal pain regimen, regardless of procedure and anesthesia type, reduces pain from moderate to mild post-hemorrhoidectomy. This approach also decreases opioid and non-opioid analgesic requirements. Higher BMI and younger age are identified as risk factors for elevated postoperative pain.
Asunto(s)
Analgésicos Opioides , Hemorreoidectomía , Dimensión del Dolor , Dolor Postoperatorio , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Analgésicos/uso terapéutico , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/administración & dosificación , Hemorreoidectomía/efectos adversos , Hemorroides/cirugía , Meperidina/uso terapéutico , Meperidina/administración & dosificación , Manejo del Dolor/métodos , Dolor Postoperatorio/etiología , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Factores de Riesgo , Tramadol/uso terapéutico , Tramadol/administración & dosificación , Resultado del TratamientoRESUMEN
We aimed to examine the efficacy of combination therapies of Neurotropin® with tramadol and Neurotropin with mirogabalin for neuropathic pain management. A neuropathic pain model (L5 spinal nerve ligation model: L5-SNL) using male Wistar rats was generated through tight ligation of the left fifth lumbar nerve using silk sutures. Mechanical allodynia was assessed using the 50% paw withdrawal threshold. The combined antiallodynic effects were evaluated using isobolographic analyses. Small intestinal transit was evaluated using the charcoal meal test, and motor coordination using the rota-rod test. Neurotropin (50-200 NU/kg, p.o.), tramadol (7.5-60 mg/kg, p.o.), and mirogabalin (3-30 mg/kg, p.o.) showed a dose-dependent antiallodynic effect in L5-SNL rats. The combined antiallodynic effects of Neurotropin and tramadol were additive or synergistic, whereas those of Neurotropin and mirogabalin were additive. Neurotropin (100-400 NU/kg, p.o.) did not affect the small intestinal transit, whereas tramadol (30-100 mg/kg, p.o.) significantly inhibited it. Neurotropin (100-400 NU/kg, p.o.) did not affect the walking time, whereas mirogabalin (10-100 mg/kg, p.o.) significantly decreased it. Neurotropin dose-dependently ameliorated mechanical allodynia in rats, and combination therapy with Neurotropin-tramadol or Neurotropin-mirogabalin may alleviate neuropathic pain without aggravating the adverse effects of tramadol and mirogabalin.
Asunto(s)
Modelos Animales de Enfermedad , Hiperalgesia , Neuralgia , Ratas Wistar , Nervios Espinales , Tramadol , Animales , Tramadol/administración & dosificación , Tramadol/farmacología , Masculino , Neuralgia/tratamiento farmacológico , Hiperalgesia/tratamiento farmacológico , Nervios Espinales/efectos de los fármacos , Ligadura/efectos adversos , Quimioterapia Combinada , Relación Dosis-Respuesta a Droga , Ratas , Tránsito Gastrointestinal/efectos de los fármacos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/farmacología , Compuestos Bicíclicos con Puentes , PolisacáridosRESUMEN
BACKGROUND AND OBJECTIVES: New acute pain medications are needed that provide effective analgesia while minimizing side effects and opioid exposure. Clinical trials of co-crystal of tramadol-celecoxib (CTC) have demonstrated an improved benefit/risk profile versus tramadol or celecoxib alone. We pooled data from two phase 3 clinical trials to evaluate the efficacy of CTC 200 mg twice daily (BID) in acute moderate-to-severe pain. METHODS: Efficacy data were pooled from STARDOM1 [acute pain following oral surgery (NCT02982161)] and ESTEVE-SUSA-301 [acute pain following bunionectomy (NCT03108482)]. The primary efficacy outcome was sum of pain intensity difference from 0 to 48 h (SPID0-48). RESULTS: A total of 344 patients received CTC 200 mg BID, 342 received tramadol 50 or 100 mg four times a day, 181 received celecoxib 100 mg BID, and 172 received placebo. The least-squares mean difference in SPID0-48 was -21.8 (p = 0.002) for CTC versus tramadol and -72.8 (p < 0.001) for CTC versus placebo. A similar pattern of SPID0-48 was observed with CTC versus comparator whether patients had moderate or severe pain at baseline. Reduction in pain intensity was faster and reached mild intensity earlier with CTC versus comparators. Patients were significantly (p ≤ 0.005) less likely to receive rescue medication within 4 or 48 h with CTC compared with tramadol or placebo. CONCLUSIONS: This pooled analysis reinforces the efficacy profile of CTC versus tramadol and, given that CTC permits lower daily tramadol dosing and thereby reduces unnecessary opioid use, this highlights its improved benefit/risk profile and its potential for the management of moderate-to-severe pain.
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Dolor Agudo , Analgésicos Opioides , Celecoxib , Tramadol , Humanos , Tramadol/uso terapéutico , Tramadol/administración & dosificación , Celecoxib/uso terapéutico , Celecoxib/administración & dosificación , Persona de Mediana Edad , Masculino , Femenino , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/administración & dosificación , Dolor Agudo/tratamiento farmacológico , Adulto , Anciano , Combinación de Medicamentos , Ensayos Clínicos Fase III como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Dimensión del Dolor , Resultado del TratamientoRESUMEN
OBJECTIVE: To explore preemptive analgesic effect of preoperative intramural tramadol injection in percutaneous kyphoplasty (PKP) of vertebrae following local anesthesia. METHODS: From August 2019 to June 2021, 118 patients with thoraco lumbar osteoporotic fractures were treated and divided into observation group and control group, with 59 patients in each gruop. In observation group, there were 26 males and 33 females, aged from 57 to 80 years old with an average of (67.69±4.75)years old;14 patients on T11, 12 patients on T12, 18 patients on L1, 15 patients on L2;tramadol with 100 mg was injected intramuscularly half an hour before surgery in observation group. In control group, there were 24 males and 35 females, aged from 55 to 77 years old with an average of (68.00±4.43) years old;19 patients on T11, 11 patients on T12, 17patients on L1, 12 patients on L2;the same amount of normal saline was injected intramuscularly in control group. Observation indicators included operation time, intraoperative bleeding, visual analogue scale (VAS) evaluation and recording of preoperative (T0), intraoperative puncture(T1), and working cannula placement (T2) between two groups of patients, at the time of balloon dilation (T3), when the bone cement was injected into the vertebral body (T4), 2 hours after the operation (T5), and the pain degree at the time of discharge(T6);adverse reactions such as dizziness, nausea and vomiting were observed and recorded;the record the patient's acceptance of repeat PKP surgery. RESULTS: All patients were successfully completed PKP via bilateral pedicle approach, and no intravenous sedative and analgesic drugs were used during the operation. There was no significant difference in preoperative general data and VAS(T0) between two groups (P>0.05). There was no significant difference in operation time and intraoperative blood loss between the two groups (P>0.05). VAS of T1, T2, T3, T4 and T5 in observation group were all lower than those in control group(P<0.05), and there was no significant difference in T6 VAS (P>0.05). T6 VAS between two groups were significantly lower than those of T0, and the difference was statistically significant (P<0.05). There was no significant difference in incidence of total adverse reactions between two groups (P>0.05). There was a statistically significant difference in the acceptance of repeat PKP surgery (P<0.05). CONCLUSION: Half an hour before operation, intramuscular injection of tramadol has a clear preemptive analgesic effect for PKP of single-segment thoracolumbar osteoporotic fracture vertebral body under local anesthesia, which could increase the comfort of patients during operation and 2 hours after operation, and improve patients satisfaction with surgery.
Asunto(s)
Anestesia Local , Cifoplastia , Vértebras Lumbares , Fracturas Osteoporóticas , Vértebras Torácicas , Tramadol , Humanos , Femenino , Masculino , Anciano , Tramadol/administración & dosificación , Persona de Mediana Edad , Cifoplastia/métodos , Vértebras Torácicas/cirugía , Vértebras Torácicas/lesiones , Fracturas Osteoporóticas/cirugía , Vértebras Lumbares/cirugía , Anestesia Local/métodos , Anciano de 80 o más Años , Analgesia/métodos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Fracturas de la Columna Vertebral/cirugía , Analgésicos Opioides/administración & dosificaciónRESUMEN
OBJECTIVES: Multimodal pain management is one component in enhanced recovery after surgery protocol. Here we evaluate the efficacy of tramadol-paracetamol in acute postoperative pain and pain outcome at 12 months after spine surgery in randomized, double-blind, placebo-controlled trial. METHODS: We randomized 120 patients undergoing spine surgery to receive, for add-on pain management, two tramadol-paracetamol 37.5 mg/325 mg (n = 61) or placebo tablets (n = 59) twice a day for 5 postoperative days. In the hospital, multimodal pain management consisted of dexketoprofen and oxycodone. After discharge, patients were prescribed ibuprofen 200 mg, maximum 1,200 mg/day. Pain, analgesic use, and satisfaction with pain medication were followed up with the Brief Pain Inventory questionnaire before surgery and at 1 and 52 weeks after surgery. The primary outcome was patients' satisfaction with pain medication 1 week after surgery. RESULTS: At 1 week after surgery, patients' satisfaction with pain medication was similarly high in the two groups, 75% [interquartile range, 30%] in the placebo group and 70% [40%] in the tramadol-paracetamol group (p = 0.949) on a scale: 0% = not satisfied, 100% = totally satisfied. At 1 week, ibuprofen dose was lower in the placebo group 200 mg [1,000] compared to the tramadol-paracetamol group, 800 mg [1,600] (p = 0.016). There was no difference in the need for rescue oxycodone. Patients in the tramadol-paracetamol group had more adverse events associated with analgesics during the first postoperative week (relative risk = 1.8, 95% confidence interval, 1.2-2.6). CONCLUSION: Add-on pain treatment with tramadol-paracetamol did not enhance patients' satisfaction with early pain management after back surgery.
Asunto(s)
Acetaminofén , Analgésicos Opioides , Dolor Postoperatorio , Tramadol , Humanos , Dolor Postoperatorio/tratamiento farmacológico , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Método Doble Ciego , Acetaminofén/administración & dosificación , Acetaminofén/uso terapéutico , Masculino , Femenino , Persona de Mediana Edad , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Satisfacción del Paciente , Oxicodona/administración & dosificación , Oxicodona/uso terapéutico , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/uso terapéutico , Adulto , Columna Vertebral/cirugía , Resultado del Tratamiento , Ibuprofeno/administración & dosificación , Ibuprofeno/uso terapéutico , Dimensión del Dolor , AncianoRESUMEN
The multimodal analgesia strategy for acute pain involves using 2 or more analgesic medications with distinct mechanisms of action. This study assessed the bioavailability and tolerability of 2 tramadol hydrochloride (50 mg)/diclofenac sodium (50 mg) fixed-dose combination formulations under fed conditions to attend the Brazilian regulatory requirements for generic product registration. An open-label, randomized, single-dose, 2-period, 2-way crossover trial was conducted, including healthy subjects of both sexes. Subjects received a single dose of either the test or reference formulation of tramadol/diclofenac fixed-dose combination tablets with a 7-day washout period. Blood samples were collected up to 36 hours after dosing for tramadol and 12 hours for diclofenac and quantified using a validated liquid chromatography-tandem mass spectrometry method. Of 56 subjects enrolled, 53 completed the study. The 90% confidence intervals for maximum plasma concentration and area under the concentration-time curve from time 0 to the last quantifiable concentration were within acceptable bioequivalence limits of 80%-125%. Considering the results presented in this study, the test formulation is bioequivalent to the reference formulation and could be interchangeable in medical practice.
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Dolor Agudo , Analgésicos Opioides , Área Bajo la Curva , Disponibilidad Biológica , Estudios Cruzados , Diclofenaco , Combinación de Medicamentos , Medicamentos Genéricos , Equivalencia Terapéutica , Tramadol , Humanos , Masculino , Tramadol/farmacocinética , Tramadol/administración & dosificación , Diclofenaco/farmacocinética , Diclofenaco/administración & dosificación , Femenino , Adulto , Medicamentos Genéricos/farmacocinética , Medicamentos Genéricos/administración & dosificación , Medicamentos Genéricos/efectos adversos , Adulto Joven , Dolor Agudo/tratamiento farmacológico , Analgésicos Opioides/farmacocinética , Analgésicos Opioides/administración & dosificación , Antiinflamatorios no Esteroideos/farmacocinética , Antiinflamatorios no Esteroideos/administración & dosificación , Persona de Mediana Edad , Brasil , Manejo del Dolor/métodos , Voluntarios Sanos , Espectrometría de Masas en TándemRESUMEN
BACKGROUND: This study investigated the outcomes up to 12 weeks after serial lidocaine infusion for early-onset peripheral neuropathic pain. METHODS: This pilot double-blind, randomized, 2-arm placebo-controlled trial recruited 50 participants with onset of peripheral neuropathic pain within the past 6 months and randomized them to either receive lidocaine (3 mg/kg) in normal saline (50 mL) intravenous infusion over 1 hour (lidocaine group) once a week for 4 weeks or 50 mL of normal saline infusion (placebo group) once a week for 4 weeks. Twenty-nine participants completed the protocol; 15 participants were assigned to the lidocaine group and 14 to the placebo group. The outcomes were pain intensity assessed using a numerical rating scale (NRS), quality of life assessed using EuroQol-Five Dimensions-Five Levels questionnaire (EQ-5D-5L), psychological function using the Thai version of the 21-item Depression Anxiety Stress Scales (DASS-21), pain medication use, and adverse effects, all assessed at baseline (BL) and again at 4, 8, and 12 weeks following randomization. RESULTS: The reported tramadol use at 8 and 12 weeks following the first infusion was significantly lower in the lidocaine group (Pâ =â .023). No other significant between-group differences were observed at any time point or for any other outcome, and no serious adverse events were observed. CONCLUSION: Multiple lidocaine infusions of 3 mg/kg once a week for 4 weeks in participants with recent onset of peripheral neuropathic pain demonstrated no significant benefits in pain intensity, quality of life, or psychological outcomes. At most, this treatment may result in less tramadol use.
Asunto(s)
Anestésicos Locales , Lidocaína , Neuralgia , Dimensión del Dolor , Calidad de Vida , Humanos , Lidocaína/administración & dosificación , Método Doble Ciego , Femenino , Masculino , Proyectos Piloto , Neuralgia/tratamiento farmacológico , Anestésicos Locales/administración & dosificación , Anestésicos Locales/uso terapéutico , Persona de Mediana Edad , Infusiones Intravenosas , Resultado del Tratamiento , Adulto , Tramadol/administración & dosificación , Tramadol/uso terapéutico , AncianoAsunto(s)
Analgésicos Opioides , Servicio de Urgencia en Hospital , Tramadol , Humanos , Tramadol/administración & dosificación , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Inyecciones Subcutáneas , Administración Intravenosa , Masculino , Femenino , Persona de Mediana EdadAsunto(s)
Analgésicos Opioides , Servicio de Urgencia en Hospital , Tramadol , Humanos , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Tramadol/efectos adversos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Inyecciones Subcutáneas , Administración Intravenosa , Dolor/tratamiento farmacológico , Dolor/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Heridas y Lesiones/complicaciones , Heridas y Lesiones/tratamiento farmacológicoAsunto(s)
Analgésicos Opioides , Servicio de Urgencia en Hospital , Tramadol , Humanos , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Tramadol/efectos adversos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Inyecciones Subcutáneas , Administración Intravenosa , Dolor/tratamiento farmacológico , Dolor/etiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Heridas y Lesiones/tratamiento farmacológico , Heridas y Lesiones/complicaciones , Dimensión del DolorRESUMEN
OBJECTIVE: A new block, namely, modified thoracoabdominal nerves block through perichondrial approach, is administered below the costal cartilage. We sought to compare the analgesic efficacy of the modified thoracoabdominal nerves block through perichondrial approach block with local anesthetic infiltration at the port sites in an adult population who underwent laparoscopic cholecystectomy. METHODS: Patients who will undergo laparoscopic cholecystectomy were randomized to receive bilateral ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach blocks or local anesthetic infiltration at the port insertion sites. The primary outcome was the total amount of tramadol used in the first 12 h postoperatively. The secondary outcomes were total IV tramadol consumption for the first postoperative 24 h and visual analog scale scores. RESULTS: The modified thoracoabdominal nerves block through perichondrial approach group had significantly less tramadol use in the first 12 h postoperatively (p<0.001). The modified thoracoabdominal nerves block through perichondrial approach group's visual analog scale scores at rest (static) and with movement (dynamic) were significantly lower compared with the port infiltration group (p<0.05). CONCLUSION: Patients who received modified thoracoabdominal nerves block through perichondrial approach block had significantly less analgesic consumption and better pain scores than those who received port-site injections after laparoscopic cholecystectomy.
Asunto(s)
Anestésicos Locales , Colecistectomía Laparoscópica , Bloqueo Nervioso , Dimensión del Dolor , Dolor Postoperatorio , Tramadol , Humanos , Colecistectomía Laparoscópica/métodos , Masculino , Femenino , Bloqueo Nervioso/métodos , Dolor Postoperatorio/prevención & control , Adulto , Persona de Mediana Edad , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Anestésicos Locales/administración & dosificación , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Resultado del Tratamiento , Ultrasonografía Intervencional/métodosRESUMEN
OBJECTIVE: Erector spinae plane block is an updated method than paravertebral block, possessing a lower risk of complications. This study aimed to compare erector spinae plane and paravertebral blocks to safely reach the most efficacious analgesia procedure in laparoscopic cholecystectomy cases. METHODS: The study included 90 cases, aged 18-70 years, classified as American Society of Anesthesiologists I-II, who underwent an laparoscopic cholecystectomy procedure. They were randomly separated into three groups, namely, Control, erector spinae plane, and paravertebral block. No block procedure was applied to Control, and a patient-controlled analgesia device was prepared containing tramadol at a 10 mg bolus dose and a 10-min locked period. The pain scores were recorded with a visual analog scale for 24 h postoperatively. RESULTS: The visual analog scale values at 1, 5, 10, 20, and 60 min at rest and 60 min coughing were found to be significantly higher in Control than in paravertebral block. A significant difference was revealed between Control vs. paravertebral block and paravertebral block vs. erector spinae plane in terms of total tramadol consumption (p=0.006). Total tramadol consumption in the first postoperative 24 h was significantly reduced in the paravertebral block compared with the Control and erector spinae plane groups. CONCLUSION: Sonography-guided-paravertebral block provides sufficient postoperative analgesia in laparoscopic cholecystectomy surgery. Erector spinae plane seems to attenuate total tramadol consumption.
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Colecistectomía Laparoscópica , Bloqueo Nervioso , Dimensión del Dolor , Dolor Postoperatorio , Tramadol , Humanos , Colecistectomía Laparoscópica/métodos , Persona de Mediana Edad , Adulto , Bloqueo Nervioso/métodos , Masculino , Femenino , Dolor Postoperatorio/prevención & control , Anciano , Adulto Joven , Adolescente , Tramadol/administración & dosificación , Analgésicos Opioides/administración & dosificación , Resultado del Tratamiento , Músculos Paraespinales/inervación , Analgesia Controlada por el Paciente/métodos , Factores de TiempoRESUMEN
BACKGROUND: Post-operative pain control improves patient's satisfaction and affects the period of admission. Local wound infiltration following hernia surgery using xylocaine or bupivacaine has been a common practice. The use of tramadol for such infiltration is relatively new and has not been studied in our environment. This study compared the efficacy of post-operative pain control between Bupivacaine and Tramadol wound infiltration in children who underwent herniotomy and orchidopexy. MATERIALS AND METHODS: This was a prospective randomised study involving 104 patients. A simple random method was used to allocate the study group into two equal groups (A, n = 52 and B, n = 52) using sealed envelopes with contents labelled A or B. Pre- and post-operative respiratory rate, heart rate, and C-reactive protein (CRP) were all recorded. Time to first and subsequent analgesia was determined using face, legs, activity, cry, consolability (FLACC) pain score. RESULTS: Fifteen patients in Group A and 18 patients in Group B received each two doses of supplemental analgesia within the first 24 h, ( P = 0.527). Time to first analgesia was significantly different between the two groups, (6.93 ± 0.80 h and 6.11 ± 1.08 h, P = 0.020). The mean FLACC pain score at the time of first analgesia in hours was 4.93 ± 0.59 and 4.72 ± 0.67 for Group A and B, respectively, P = 0.350. The changes in CRP were not different in the two groups, ( P = 0.665). Four patients in Group A, but none in Group B had an episode each of post-operative vomiting. CONCLUSION: Tramadol showed comparable efficacy with bupivacaine in post-operative pain control by wound infiltration in children who had unilateral herniotomy or orchidopexy. Tramadol, however, achieves a longer duration of action before rescue analgesic is required. Caution is necessary to avoid post-operative vomiting.
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Analgésicos Opioides , Anestésicos Locales , Bupivacaína , Hernia Inguinal , Herniorrafia , Orquidopexia , Dimensión del Dolor , Dolor Postoperatorio , Tramadol , Humanos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Tramadol/administración & dosificación , Bupivacaína/administración & dosificación , Anestésicos Locales/administración & dosificación , Orquidopexia/métodos , Masculino , Estudios Prospectivos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Preescolar , Niño , Femenino , Hernia Inguinal/cirugía , Resultado del Tratamiento , Anestesia Local/métodos , Manejo del Dolor/métodosRESUMEN
BACKGROUND: Pain management is essential after discectomy, the surgical treatment for lumbar disc herniation. This study evaluated the effect of sacral erector spinae plane block (SESPB) versus standard analgesic methods on postoperative analgesia and opioid consumption in lumbar discectomy operations. METHODS: Over 18 years of age, ASA 1-3 group, 54 patients undergoing elective lumbar discectomy were included in the prospective, randomized, controlled, double-blind, study. They were randomly divided into groups, SESPB and non-block (control). Both groups completed surgery under general anesthesia. At the end of the surgery, group SESPB received a bilateral 20 cc block with 0.25% bupivacaine at the level of the second sacral vertebra. Both groups received tramadol via a patient-controlled analgesia (PCA) device. The primary outcome was total opioid consumption in the first 24 hours after surgery. Pain assessment by Visual Analog Scale (VAS), rescue analgesic requirements, time to first rescue analgesic requirement and adverse effects were recorded 24 hours postoperatively. RESULTS: Total tramadol consumption was 168.8±143 mg (P<0.04) higher in the control group. The first six-hour VAS scores and the number of rescue analgesic users were lower in the SESPB group (P<0.01). The first rescue analgesic use time was 440±140.3 minutes in SESPB group and 47.5±116.1 minutes in control group (P<0.01). Nausea-vomiting was more frequent in the control group (P<0.01) and patient satisfaction was higher in the SESPB group (P<0.01). CONCLUSIONS: In lumbar discectomy surgery, ultrasound-guided SESPB provided adequate analgesia by reducing opioid consumption and pain scores without complications.
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Discectomía , Vértebras Lumbares , Bloqueo Nervioso , Dolor Postoperatorio , Ultrasonografía Intervencional , Humanos , Dolor Postoperatorio/prevención & control , Dolor Postoperatorio/tratamiento farmacológico , Masculino , Método Doble Ciego , Bloqueo Nervioso/métodos , Femenino , Adulto , Estudios Prospectivos , Vértebras Lumbares/cirugía , Persona de Mediana Edad , Músculos Paraespinales/inervación , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/administración & dosificación , Dimensión del Dolor , Tramadol/uso terapéutico , Tramadol/administración & dosificaciónRESUMEN
BACKGROUND: With the rising toll of the opioid crisis, oculoplastic surgeons have been looking at methods to decrease opioid prescription. OBJECTIVES: The aim of this study was to identify factors that correlate with opioid usage after oculoplastic surgery. METHODS: This was a prospective study conducted at University of Texas Southwestern. All patients who underwent an oculoplastic procedure were eligible for inclusion. Patients enrolled were provided 20 tablets of tramadol 50 mg, to take 1 tablet every 6â hours as needed for pain. At their postoperative week 1 appointment, participants had the remaining number of unused opioid tablets counted. The number of tablets taken were calculated by subtracting the remaining number of tablets from the original prescribed amount. RESULTS: A total of 310 patients were enrolled in our study. Of these, 129 patients met the inclusion criteria. There was a statistically significant difference in the number of tramadol tablets taken between procedures for upper eyelids, lower eyelids, and both eyelids (P < .01). There were no statistically significant differences in tramadol usage when comparing procedures on eyelids with orbit procedures(P = .30), cosmetic with noncosmetic procedures (P = .52), males with females (P = .87), or patients naive to oculoplastic procedures with those undergoing reoperation (P = .58). Longer procedures were correlated with greater tramadol usage (R = 0.28, P < .01). CONCLUSIONS: This is the first study in the literature that has objectively quantified opioid usage after oculoplastic surgery in a prospective manner. Procedures that involve both upper and lower eyelids simultaneously and longer procedures resulted in higher opioid use. Orbital procedures, cosmetic procedures, sex, and procedural naivety were not found to be associated with higher opioid usage.
Asunto(s)
Analgésicos Opioides , Dolor Postoperatorio , Tramadol , Humanos , Masculino , Femenino , Estudios Prospectivos , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/etiología , Persona de Mediana Edad , Tramadol/administración & dosificación , Adulto , Anciano , Adulto Joven , Párpados/cirugía , Texas , Factores de Tiempo , Prescripciones de Medicamentos/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricosRESUMEN
BACKGROUND: Multimodal analgesia for total hip arthroplasty (THA) is increasingly employed to reduce early postoperative pain and promote fast patient discharge. The aim of this study was to compare the efficacy and tolerability of tramadol/dexketoprofen (TRAM/DKP, Group A) versus paracetamol + tramadol (PARA+TRAM, Group B) in patients undergoing THA using minimally invasive direct anterior approach (DAA). METHODS: A single-centre, randomised, single-blind, parallel, interventional study conducted in 323 patients undergoing primary THA with DAA was performed. Group A consisted of 188 patients and Group B of 135. The primary endpoints were the change from baseline (measured 2 hours postoperatively) in pain intensity (PI) during the treatment period (48 hours), assessed by visual analogue scale (VAS) at pre-specified postoperative time-points (2, 8, 24, 48 hours) and the total rescue medication (RM) use during the first 24 hours postoperatively. RESULTS: As early as 2 hours after baseline, Group A showed a greater PI reduction from baseline compared to Group B (-26.24% vs. -6.87%; p < 0.001). A lower mean PI (VAS) score was consistently found over the entire observation period following treatment with TRAM/DKP than with PARA+TRAM as well as more than 2-fold higher proportion of responders at the end of treatment period. More patients in Group B required RM in comparison to those in Group A (15.6% vs. 3.7%, p < 0.001). Both treatments were well tolerated. CONCLUSIONS: After THA, oral TRAM/DKP provides faster and greater pain relief when compared to intravenous PARA+TRAM with limited consumption of RM and favourable tolerability profile. Our study expands the use of TRAM/DKP in the setting of major orthopaedic surgeries. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT04178109).