دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | 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. |
| المصدر: | Journal of clinical anesthesia [J Clin Anesth] 2024 Aug; Vol. 95, pp. 111451. Date of Electronic Publication: 2024 Apr 03. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 8812166 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-4529 (Electronic) Linking ISSN: 09528180 NLM ISO Abbreviation: J Clin Anesth Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2008->: New York : Elsevier Original Publication: [Stoneham, MA] : Butterworths, [c1988- |
| مواضيع طبية MeSH: | Analgesics, Opioid*/administration & dosage , Ankle*/surgery , Foot*/surgery , Nerve Block*/methods , Pain, Postoperative*/prevention & control , Pain, Postoperative*/etiology , Pain, Postoperative*/drug therapy , Sciatic Nerve*, Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Ambulatory Surgical Procedures/adverse effects ; Ambulatory Surgical Procedures/methods ; Anesthetics, Local/administration & dosage ; Netherlands ; Pain Measurement ; Patient Reported Outcome Measures ; Patient Satisfaction ; Treatment Outcome |
| مستخلص: | 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. Competing Interests: Declaration of competing interest The authors declare no conflict of interest regarding the submitted work. Outside the submitted manuscript, MWH serves as Executive Section Editor Pharmacology with Anesthesia and Analgesia and Section Editor Anesthesiology with the Journal of Clinical Medicine, Editor with Frontiers in Physiology and he served as consultant for PAION, IDD & Medical Developments Pharma. (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Ambulatory continuous peripheral nerve blockade; Analgesia; Nerve block; Opioid; Postoperative pain |
| المشرفين على المادة: | 0 (Analgesics, Opioid) 0 (Anesthetics, Local) |
| تواريخ الأحداث: | Date Created: 20240404 Date Completed: 20240427 Latest Revision: 20240819 |
| رمز التحديث: | 20240819 |
| DOI: | 10.1016/j.jclinane.2024.111451 |
| PMID: | 38574504 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1873-4529 |
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| DOI: | 10.1016/j.jclinane.2024.111451 |