The Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) on Postoperative Pain and Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- numerical rating scale scores
研究概览
简要总结
Objective: To investigate the postoperative analgesic efficacy of M-TAPA block and its effect on opioid consumption in patients undergoing laparoscopic cholecystectomy (LC) surgery.
Place and Duration of Study: Department of Anesthesiology and Reanimaton, Sivas Cumhuriyet University, Sivas, Turkey, from April 2023 to May 2023.
Methodology: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain. Numerical rating scale (NRS) and visual analogue scale (VAS) were used to assess postoperative pain. Total tramadol consumption was calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
排除标准
- •Patients who did not give consent,
- •patients with coagulopathy,
- •patients with signs of infection at the block application site,
- •patients using anticoagulants,
- •patients with local anesthetic drug allergies,
- •patients undergoing open surgery,
- •patients with unstable hemodynamics,
- •patients who could not cooperate during postoperative pain assessment
结局指标
主要结局
numerical rating scale scores
时间窗: postoperative 24 hours
numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
次要结局
- total tramadol consumption(postoperative 24 hours)
研究者
Oguz Gundogdu
Assisstant Professore
Cumhuriyet University