Comparison of Post-operative Analgesic Efficacy of the Ultrasound-guided Bilateral Modified Thoracoabdominal Nerves Block through Perichondrial Approach (M-TAPA) and Ultrasound-guided Bilateral External Oblique Intercoastal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy : A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Total analgesic consumption in the first 24 hours of the postoperative period
研究概览
简要总结
Laparoscopic cholecystectomy is one of the most frequently performed procedures and has a short postoperative hospital stay. Even though laparoscopic cholecystectomy results in less postoperative pain than open cholecystectomy, severe pain is a common complaint, particularly in the first 24 hours. The effectiveness of ultrasound-guided inter-fascial plane blocks has recently come to the fore in the field of regional anaesthesia and pain management.
This study will be a randomized double-blinded clinical study to compare the postoperative analgesic efficacy of ultrasound guided bilateral modified thoracoabdominal nerve block through perichondrial approach and ultrasound-guided bilateral external oblique intercostal plane block in patients undergoing elective laparoscopic cholecystectomy.
After approval from the research ethics board of RIMS, Imphal, a total number of 58 patients (18-65 years, ASA I and II, BMI < 30kg/m2) will be randomized into one of the two groups (n=29) after taking written informed consent from the patients. Following anaesthesia induction and patient intubation, group M-TAPA will receive a modified thoracoabdominal nerve block through a perichondrial approach with 20ml of inj. Ropivacaine 0.25% bilaterally and group EOIPB will receive an external oblique intercostal plane blocks with 20ml of Inj. Ropivacaine 0.25% bilaterally.
Postoperatively patients will be shifted to PACU, where the assessment of VRS scores, will be recorded at designated periods. Total analgesic consumption up to 24 hours, and time of first rescue analgesia will be recorded. Data will be recorded in a proforma tabulated in the EXCEL software and analyzed using IBM SPSS Version 26 software. A p-value of less than 0.05 will be taken as statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age group 18-65 years.
- •Patients of American Society of Anaesthesiologists (ASA) physical status I or II.
排除标准
- •Patients with active block injection site infections.
- •Patients on anticoagulants or clinically significant coagulopathy.
- •Patients with history of hypersensitivity to amide group of local anaesthetic agents.
- •Patients receiving opioids for chronic analgesic therapy.
- •Patients with preoperative use of any pain reliever within 24 hours.
- •Patients with alcohol use or drug use (daily usage for the past 1 month).
- •Patients with body mass index (BMI) more than 30kgm-2.
结局指标
主要结局
Total analgesic consumption in the first 24 hours of the postoperative period
时间窗: 1st 24 hours of post-operative period
次要结局
- Comparing the VRS scores at rest and movement in the first 24 hours of the postoperative period(VRS scores will be assessed at rest and movement in the first 24 hours of the postoperative period)