Liposomal Bupivacaine Versus Ropivacaine for Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Randomized, Single-Blind, Parallel-Group Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Postoperative dynamic NRS pain score at 24 hours
研究概览
简要总结
This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a single-blind trial with blinded outcome assessment. The patients, outcome assessors, and statistical analysts are blinded to the group allocation. Only the anesthesiologist performing the transversus abdominis plane (TAP) block is aware of the treatment assignment, to ensure the safety and standardization of the procedure.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, either gender.
- •Patients scheduled for elective laparoscopic cholecystectomy.
- •ASA physical status I-III.
- •Able to provide written informed consent and complete the 3-month follow-up.
排除标准
- •History of allergy to local anesthetics.
- •History of dementia, psychosis, or other central nervous system diseases.
- •History of chronic pain or long-term use of opioids or other analgesics.
- •Contraindications to nerve block: infection at puncture site, severe coagulopathy.
- •Severe hepatic or renal dysfunction, pregnancy, or lactation.
研究组 & 干预措施
Liposomal Bupivacaine Group
Patients in this group will receive transversus abdominis plane (TAP) block with liposomal bupivacaine after surgery.
干预措施: Liposomal Bupivacaine TAP block (Drug)
Ropivacaine group
Patients in this group will receive transversus abdominis plane (TAP) block with Ropivacaine after surgery.
干预措施: Ropivacaine TAP blocks (Drug)
结局指标
主要结局
Postoperative dynamic NRS pain score at 24 hours
时间窗: 24 hours after surgery
Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).
次要结局
- Postoperative NRS pain scores at different time points(24, 48, and 72 hours after surgery)
- Postoperative recovery quality (QoR-15 scale)(24, 48, and 72 hours after surgery)
- Time to first rescue analgesia(Up to 72 hours after surgery)
- Total postoperative analgesic consumption within 72 hours(72 hours after surgery)
- Gastrointestinal function recovery(Postoperatively, through hospital discharge, up to 7 days after surgery)
- Postoperative length of hospital stay(Postoperatively, through hospital discharge (up to 7 days))
- Incidence of adverse events(Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery))
研究者
Lili Jia
Attending Physician
Tianjin First Central Hospital