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The effectiveness of ambulatory continuous popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia in patients undergoing foot or ankle surgery (CAREFREE trial); a randomized, open label, non-inferiority trial.
Admiraal, Manouk; Smulders, Pascal S H; Rutten, Martin V H; de Groot, Eelko K; Heine, Yvonne; Baumann, Holger M; van der Vegt, Vincent H C; Halm, Jens A; Hermanns, Henning; Schepers, Tim; Hollmann, Markus W; Hermanides, Jeroen; Ten Hoope, Werner.
Afiliación
  • Admiraal M; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Smulders PSH; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Rutten MVH; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • de Groot EK; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Heine Y; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Baumann HM; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • van der Vegt VHC; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Halm JA; Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Hermanns H; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands. Electronic address: h.hermanns@amsterdamumc.nl.
  • Schepers T; Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Hollmann MW; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Hermanides J; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
  • Ten Hoope W; Department of Anesthesiology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands; Department of Anesthesiology, Rijnstate Hospital, Wagnerlaan 55, 6815 AD Arnhem, the Netherlands.
J Clin Anesth ; 95: 111451, 2024 08.
Article en En | MEDLINE | ID: mdl-38574504
ABSTRACT
STUDY

OBJECTIVE:

Management of pain after foot and ankle surgery remains a concern for patients and healthcare professionals. This study determined the effectiveness of ambulatory continuous popliteal sciatic nerve blockade, compared to standard of care, on overall benefit of analgesia score (OBAS) in patients undergoing foot or ankle surgery. We hypothesized that usage of ambulatory continuous popliteal sciatic nerve blockade is non-inferior to standard of care.

DESIGN:

Single center, randomized, non-inferiority trial.

SETTING:

Tertiary hospital in the Netherlands. PATIENTS Patients were enrolled if ≥18 years and scheduled for elective inpatient foot or ankle surgery. INTERVENTION Patients were randomized to ambulatory continuous popliteal sciatic nerve blockade or standard of care. MEASUREMENTS The primary outcome was the difference in OBAS, which includes pain, side effects of analgesics, and patient satisfaction, measured daily from the first to the third day after surgery. A non-inferiority margin of 2 was set as the upper limit for the 90% confidence interval of the difference in OBAS score. Mixed-effects modeling was employed to analyze differences in OBAS scores over time. Secondary outcome was the difference in opioid consumption. MAIN

RESULTS:

Patients were randomized to standard of care (n = 22), or ambulatory continuous popliteal sciatic nerve blockade (n = 22). Analyzing the first three postoperative days, the OBAS was significantly lower over time in the ambulatory continuous popliteal sciatic nerve blockade group compared to standard of care, demonstrating non-inferiority (-1.9 points, 90% CI -3.1 to -0.7). During the first five postoperative days, patients with ambulatory continuous popliteal sciatic nerve blockade consumed significantly fewer opioids over time compared to standard of care (-8.7 oral morphine milligram equivalents; 95% CI -16.1 to -1.4).

CONCLUSIONS:

Ambulatory continuous popliteal sciatic nerve blockade is non-inferior to standard of care with single shot popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Dolor Postoperatorio / Nervio Ciático / Pie / Analgésicos Opioides / Tobillo / Bloqueo Nervioso Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: J Clin Anesth Asunto de la revista: ANESTESIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Dolor Postoperatorio / Nervio Ciático / Pie / Analgésicos Opioides / Tobillo / Bloqueo Nervioso Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: J Clin Anesth Asunto de la revista: ANESTESIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos