Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)

Официальное название

Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for PENG Block on Post Operative Pain Management in Patients Undergoing Hip Arthroplasty: a Prospective, Randomized, Single Blind, Active Controlled Study

Обзор

The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are: 1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction? 2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery? Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery. Participants will: 1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance. 2. Undergo hip replacement surgery under spinal anesthesia. 3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.

Вмешательства

• Препарат Liposomal bupivacaine plus bupivacaine
  Liposomal bupivacaine is a prolonged-release formulation of the local anesthetic bupivacaine. This intervention involves the administration of liposomal bupivacaine plus bupivacaine as a local anesthetic for the pericapsular nerve group (PENG) block under ultrasound guidance. Liposomal bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This formulation is designed to provide extended pain relief as compared to convention
• Препарат Ropivacaine
  Ropivacaine is a commonly used local anesthetic in clinical practice, and it serves as the active comparator intervention in this study. Participants in the comparator arm will receive ropivacaine as a local anesthetic for the PENG block under ultrasound guidance.

Первичные конечные точки

• Overall Opioid Consumption [Срок оценки: this outcome will be monitored and recorded within 72 hours postoperatively]

Вторичные конечные точки (4)

• Pain intensity [Срок оценки: at multiple time points within 72 hours post-surgery.]
• Time to First Rescue Analgesic [Срок оценки: 72 hours after surgery.]
• Incidence of Complications or Adverse Events [Срок оценки: 90 days after the surgical procedure]
• Duration of Hospital Stay [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• American Society of Anesthesiologists(ASA) I\~II
• Normal coagulation
• Clinical diagnosis of hip fracture

Критерии исключения

• Presence of severe systemic diseases or ASA grade III or higher
• Allergy to amide local anesthetics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST — Ухань

Публикации

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• Temple-Oberle C, Shea-Budgell MA, Tan M, Semple JL, Schrag C, Barreto M, Blondeel P, Hamming J, Dayan J, Ljungqvist O; ERAS Society. Consensus Review of Optimal Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery (ERAS) Society Recommendations. Plast Reconstr Surg. 2017 May;139(5):1056e-1071e. doi: 10.1097/PRS.0000000000003242. PMID 28445352
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• Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy3 PMID 30304509
• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. PMID 30063657
• McCann ME. Liposomal Bupivacaine. Anesthesiology. 2021 Feb 1;134(2):139-142. doi: 10.1097/ALN.0000000000003658. No abstract available. PMID 33433621

Идентификаторы

NCT: NCT06565910 · TJ-IRB202407066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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