跳至主要内容
临床试验/CTRI/2025/08/093587
CTRI/2025/08/093587尚未招募3 期

Bilateral Transverse Abdominis Plane Block versus Local Wound Infiltration for postoperative analgesia in patients undergoing Laparoscopic Diversion Colostomy- A Randomized Control Study

Fluid Research Grant1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To provide longer and superior post operative pain relief for patients undergoing laparoscopic diversion colostomy by using TAP Block as opposed to local wound infiltration

研究概览

简要总结

Postoperative analgesia is important for enhanced recovery. Although laparoscopic surgeries have reduced the incision and pain in colorectal surgeries, postoperative pain is still an issue. Opioid based analgesia is generally used for pain management, however it can lead to increased incidences of post op nausea, vomiting, urinary retention, constipation etc. This study aims to compare the effectiveness of a bilateral TAP Block to opt for opioid free analgesic modalities and reduce the effects related to opioids after surgery. Patients undergoing laparoscopic diversion colostomy will be recruited for this study after obtaining for the study. This will be a randomized control trial and a double blinded study in which the patient and the primary investigator will be blinded. All the patients undergoing the surgery will be allotted a computer generated randomized number that will decide whether the patient will receive local wound infiltration or a TAP Block. The patient wil then be followed up in PACU and surgical wards. Postoperative pain intensity, opioid consumption, PEFR and occurence of any adverse events following the block and length of hospital stay will be evaluated in both arms.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All consenting and hemodynamically stabel patients undergoing laparoscopic diversion colostomy.

排除标准

  • Non consenting patients, patient with history of adverese events with local anesthetics, infection at site of infiltration, long term opoid use, impaired coagulation profile and ASA 4 and above.

结局指标

主要结局

To provide longer and superior post operative pain relief for patients undergoing laparoscopic diversion colostomy by using TAP Block as opposed to local wound infiltration

时间窗: Post op pain will be assessed using the VAS scores in the first 12 hours i.e. on shifting the patient to recovery, 2 hours, 4 hours, 8 hours and 12 hours.

次要结局

  • To measure the requirement of post op opioids(Need of opioids postoperatively in recovery & in the first 12 hours.)
  • To measure the difference in peak expiratory flow rate preoperatively & compare post operatively in both study arms(Preoperative PEFR will be measured in the ward or holding bay for baseline values & compared with post operative PEFR measured in ward after 2 hours, 4 hours, 8 hours & 12 hours.)
  • To evaluate the length of hospital stay(Postoperative length of hospital stay)

研究者

发起方
Fluid Research Grant
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sophia Nag

Christian Medical College

研究点 (1)

Loading locations...

相似试验

A study on two pain control techniques in... | 临床试验