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

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 under...

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Bibliographic Details
Published in:	Journal of clinical anesthesia Vol. 95; p. 111451
Main Authors:	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
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-08-2024 Elsevier Limited
Subjects:	Adult Aged Ambulatory continuous peripheral nerve blockade Ambulatory Surgical Procedures - adverse effects Ambulatory Surgical Procedures - methods Analgesia Analgesics, Opioid - administration & dosage Anesthesia Anesthetics, Local - administration & dosage Ankle Ankle - surgery Catheters Clinical outcomes Elective surgery Female Foot - surgery Hospitals Humans Intervention Male Medical personnel Middle Aged Morphine Mortality Narcotics Nerve block Nerve Block - methods Netherlands Opioid Outpatient care facilities Pain management Pain Measurement Pain, Postoperative - drug therapy Pain, Postoperative - etiology Pain, Postoperative - prevention & control Patient Reported Outcome Measures Patient Satisfaction Patient-centered care Postoperative pain Questionnaires Recovery (Medical) Sciatic Nerve Side effects Standard of care Surgery Treatment Outcome Ultrasonic imaging Netherlands Germany Opioid Analgesia Postoperative pain Nerve block Ambulatory continuous peripheral nerve blockade
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Summary:	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. •Ambulatory nerve blocks are safe and feasible in foot and ankle surgery.•Ambulatory nerve blockade is non-inferior on overall benefit of analgesia.•Reduced opioid consumption makes this a promising option for foot or ankle surgery.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	0952-8180 1873-4529 1873-4529
DOI:	10.1016/j.jclinane.2024.111451