Postoperative Analgesic Effect of Ultrasound-guided Thoracoabdominal Nerves Block Through Perichondrial Approach in Patients Undergoing Laparoscopic Cholecyctectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum postoperative pain score during 12hours postoperatively
研究概览
简要总结
This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).
详细描述
Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.
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
Participants were blinded to the allocation, because that investigator performed nerve block after induction of anesthesia. The outcome assessor not involved in this study will investigate the outcomes
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective laparoscopic cholecystectomy
- •American Society of Anesthesiologists (ASA) physical classification I-II
排除标准
- •American Society of Anesthesiologists (ASA) physical classification III or more
- •Chronic pain, chronic analgesic or antidepressant or anticonvulsant use
- •Allergies to anesthetic or analgesic medications used in the protocol
- •Single port laparoscopic cholecystectomy
- •Patients with infection at the abdominal wall
- •Medical or psychological disease that can affect the treatment response
- •Do not understand our study
结局指标
主要结局
Maximum postoperative pain score during 12hours postoperatively
时间窗: at 12hour postoperatively.
maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively
次要结局
- Postoperative pain score at rest(at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge)
- Postoperative pain score during coughing(at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge)
- Patient satisfaction before discharge(at immediately before discharge)
- Occurrence rate of postoperative nausea, vomiting(at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.)
研究者
Hojin Lee, MD
Assistant clinical professor
Seoul National University Hospital