Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

Официальное название

Analgesic Efficacy Between Liposomal Bupivacaine and Bupivacaine Hydrochloride in Intercostal Nerve Block for Thoracic Surgery: A Multicenter Randomized Controlled Trial

Обзор

This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.

Подробное описание

Background: Lung cancer surgery, even with minimally invasive thoracoscopy, causes significant postoperative pain in up to 62.9% of patients, potentially leading to complications and chronic pain. Intercostal nerve block is a safe alternative to epidural analgesia, but standard local anesthetics like bupivacaine provide limited duration (\<8 hours). Liposomal bupivacaineoffers prolonged release up to 72 hours.

Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.

Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).

Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.

Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by \>10% vs. bupivacaine and \>15% vs. control from 25-72 hours.

Вмешательства

• Процедура Liposomal Bupivacaine intercostal nerve block
  Ultrasound-guided intercostal nerve block with liposomal bupivacaine 266 mg (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.
• Процедура Bupivacaine Hydrochloride intercostal nerve block
  Ultrasound-guided intercostal nerve block with 0.25% bupivacaine hydrochloride (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.
• Другое Standard Postoperative Analgesia
  No intercostal nerve block. Patients receive standard postoperative analgesia consisting of an intravenous patient-controlled opioid pump per institutional protocol.

Первичные конечные точки

• Pain score area under the curve (AUC) from 25 to 72 hours postoperatively [Срок оценки: 25 to 72 hours after the end of surgery]

Вторичные конечные точки (2)

• Pain score at PACU discharge and postoperative intervals [Срок оценки: At PACU discharge, and 6, 12, 24, 48, and 72 hours postoperatively]
• Cumulative opioid consumption [Срок оценки: From the end of surgery to 48 hours after surgery]

Критерии участия

Критерии включения

• Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
• Age 18 to 80 years
• American Society of Anesthesiologists (ASA) physical status I-III

Критерии исключения

• Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk)
• Sensory abnormalities in the planned chest-wall surgical area
• Hepatic dysfunction (ALT > 50 U/L, AST > 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine > 112 μmol/L, BUN > 7.1 mmol/L, or dialysis within 28 days before surgery)
• Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period
• Preoperative opioid use, history of chronic pain, or history of opioid abuse
• Refusal to provide informed consent

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

• Shanghai pulmonary hospital — Шанхай

Публикации

• Huang J, Wang L, Wei S, Xin Y, Chang R, Liu H, Yang Y, Song J, Lv X. Comparison of liposomal bupivacaine and bupivacaine hydrochloride intercostal nerve blocks for postoperative analgesia after thoracic surgery: a multicenter, randomized, three arms trial protocol. Ann Med. 2026 Dec;58(1):2612384. doi: 10.1080/07853890.2025.2612384. Epub 2026 Jan 20. PMID 41560407
• Yu J, Wei S, Ling D, Xin Y, Liu H, Yang Y, Li X, Xiang Z, Liu J. Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial. Drug Des Devel Ther. 2025 Dec 26;19:11767-11778. doi: 10.2147/DDDT.S567868. eCollection 2025. PMID 41477178

Идентификаторы

NCT: NCT07134660 · 2024LY0971

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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