POST OPERATIVE ANALGESIC EFFICACY OF MODIFIED THORACO ABDOMINAL PLANE BLOCK VS LOCAL ANESTHETIC INFILTRATION AT PORT SITE IN LAPAROSCOPIC CHOLECYSTECTOMY
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the requirement of rescue analgesic IV Fentanyl in both groups for 24 hours.
研究概览
简要总结
Aim of study is to compare analgesic effectiveness of Modified thoracoabdominal nerve block via perichondrial approach(MTAPA) vs LA infiltration at port site in elective laparoscopic cholecystectomy surgeries.
Seventy patients will be enrolled for this study after inclusion and exclusion criteria. They will be allocated to one of the two groups
Written informed consent will be taken from the patients.
Group L = patients will receive local anesthetic at incision sites
Group M = patients will receive ultrasound guided MTAPA block after suturing incision sites
Following the end of the surgical operation, MTAPA/LA infiltration will be performed before reversing the patient’s from general anaesthesia. patient will be transferred to the postoperative recovery room(PACU).
Patients in both groups will receive i.v. Paracetamol 1gm 8hourly
Diclofenac 75mg if NRS>3
Fentanyl as rescue analgesic
Patient will be assessed for pain by anaesthesia resident blinded to group allocation at Â,½, 2, 4, 6, 8,12 and 24hrs in recovery room.
The severity of pain at rest and movement will be assessed using Numeric Pain Scale (NRS).
Total postoperative Analgesic consumption - (PCA fentanyl) will be recorded , Total requirement of rescue analgesic (fentanyl) for NRS >5, will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for elective laparoscopic cholecystectomy. Age.
- •18 years to 60 years American Society of Anesthesiologists (ASA) physical status classification I-II.
排除标准
- •Known allergy to local anesthetic agent (bupivacaine) infection at the injection site history of abdominal surgery pregnancy.
结局指标
主要结局
To compare the requirement of rescue analgesic IV Fentanyl in both groups for 24 hours.
时间窗: Immediate post op | 30 min post op | 1hr post op | 2hr post op | 4 hr post op | 6hr post op | 8hr post op | 12 hr post op | 24 hr post op
次要结局
- To compare the requirement of rescue antiemetic IV metoclopramide in both the groups for 24 hours.(To compare the hemodynamics in both the groups for 24 hours.)