Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
- Age 18 to 80 years
- American Society of Anesthesiologists (ASA) physical status I-III
Exclusion Criteria:
- 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
