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临床试验/CTRI/2024/09/073692
CTRI/2024/09/073692招募中4 期

The analgesic effect and patient satisfaction following bupivacaine infiltration in the extra peritoneal space in patients undergoing laparocopic TAPP repair for unilateral inguinal hernias A Randomized controlled Trial

AIIMS Jodhpur Research Section1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年9月21日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
202
试验地点
1
主要终点
Analgesic effect of bupivacine infiltration into port wounds and extraperitoneal space compared to placebo (normal saline) after 6 ,12 , 24 hours of surgery

研究概览

简要总结

The study will include all adult male inguinal hernia patients undergoing TAPP. Total 202 patients will be randomized for the study just before the procedure. The study patients will be introduced with infiltration of 0.5% bupivacaine and other patients will be introduced with normal saline in the extra-peritoneal space and port site. The study patients will be compared for postoperative outcomes likes pain at 6, 12 and 24 hours after surgery

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
Male

入选标准

  • All male patients between specified age undergoing unilateral TAPP will be included.

排除标准

  • Recuurent hernia , Previous laparotomy ,substance abuse or opium addiction , psychiatric patients, uncontrolled comorbidities, history of drug allergy.

结局指标

主要结局

Analgesic effect of bupivacine infiltration into port wounds and extraperitoneal space compared to placebo (normal saline) after 6 ,12 , 24 hours of surgery

时间窗: VAS pain score after 6 ,12 , 24 hours of surgery

次要结局

  • To compare patient satisfaction level(At time of discharge from the hospital ( 1 or 2 days after OT ))

研究者

发起方
AIIMS Jodhpur Research Section
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Satya Prakash Meena

AIIMS Jodhpur

研究点 (1)

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