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临床试验/CTRI/2021/12/038501
CTRI/2021/12/038501已完成不适用

Effect of Ultrasound-guided Ilioinguinal-Iliohypogastric Nerve Block on Chronic Pain in Patients undergoing open Inguinal Hernia surgery under Spinal Anesthesia: A Randomized Double blind pilot study.

Primary investigator1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
•chronic inguinal pain by NRS and DN4 score at 3 months after surgery.

研究概览

简要总结

Postherniorrhaphy groin pain is defined as pain lasting greater than 3 months after hernia surgery, which is one of the most important complications occurring after inguinal hernia repair.The overall incidence has been reported to be as high as 35% with an average of 10% patients reporting their pain as moderate to severe intensity. Preemptive regional nerve block (ilioinguinal & Iliohypogastric) has been found to reduce severity of acute postoperative pain and opioid consumption. However, its role in prevention of chronic pain is unclear. We hypothesize that  Ultrasound-guided ilioinguinal iliohypogastric nerve block has the potential to reduce the incidence of chronic groin pain at 3 months.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Male

入选标准

  • Patients of American Society of Anesthesiologists Physical status (ASA) I-III posted for elective open unilateral inguinal hernia surgery under spinal anesthesia who agree to participate in the study.

排除标准

  • Patients with mental retardation and communicable disorder, infection at the injection site, contraindication to a nerve block, B/L or recurrent inguinal hernia or with hydrocele will be excluded from the study.

结局指标

主要结局

•chronic inguinal pain by NRS and DN4 score at 3 months after surgery.

时间窗: -3,6,12 and 24 hours after surgery. | -3 months after surgery.

•Postoperative pain score according to numerical rating scale (NRS) at 3, 6,12 and 24 hours after surgery

时间窗: -3,6,12 and 24 hours after surgery. | -3 months after surgery.

•Total opioid consumption (in mg) in first-24 hours of postoperative period.

时间窗: -3,6,12 and 24 hours after surgery. | -3 months after surgery.

次要结局

  • •Time to first rescue analgesic (Tramadol) request by the patient(•Total opioid consumption (in mg) in first-24 hours of postoperative period)

研究者

发起方
Primary investigator
申办方类型
Private medical college

研究点 (1)

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