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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

Journal of clinical anesthesia, 2024-08, Vol.95, p.111451 [Peer Reviewed Journal]

Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved. ;EISSN: 1873-4529 ;DOI: 10.1016/j.jclinane.2024.111451 ;PMID: 38574504

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Title:
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
Author: 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
Subjects: Adult ; Aged ; Ambulatory Surgical Procedures - adverse effects ; Ambulatory Surgical Procedures - methods ; Analgesics, Opioid - administration & dosage ; Anesthetics, Local - administration & dosage ; Ankle - surgery ; Female ; Foot - surgery ; Humans ; Male ; Middle Aged ; Nerve Block - methods ; Netherlands ; Pain Measurement ; Pain, Postoperative - drug therapy ; Pain, Postoperative - etiology ; Pain, Postoperative - prevention & control ; Patient Reported Outcome Measures ; Patient Satisfaction ; Sciatic Nerve ; Treatment Outcome
Is Part Of: Journal of clinical anesthesia, 2024-08, Vol.95, p.111451
Description: 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. Single center, randomized, non-inferiority trial. Tertiary hospital in the Netherlands. Patients were enrolled if ≥18 years and scheduled for elective inpatient foot or ankle surgery. Patients were randomized to ambulatory continuous popliteal sciatic nerve blockade or standard of care. 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. 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). 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.
Publisher: United States
Language: English
Identifier: EISSN: 1873-4529
DOI: 10.1016/j.jclinane.2024.111451
PMID: 38574504
Source: MEDLINE

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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

Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved. ;EISSN: 1873-4529 ;DOI: 10.1016/j.jclinane.2024.111451 ;PMID: 38574504

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