A clinical trial to compare the effectiveness of three regional blocks for post-operative pain in children undergoing inguinal hernia repair

Phase 3

Completed

• Conditions: Diseases of male genital organs,

• Registration Number: CTRI/2019/09/021377
• Lead Sponsor: All India Institute of Medical SciencesBhubaneswar

Brief Summary

This study is a prospective Randomised controlled Trial comparing three different ultrasound guided regional blocks in patients aged 2-10yrs posted for elective open inguinal hernia surgeries. Drug used for the blocks is 0.25% Ropivacaine administered after induction of General anaesthesia. The study will be conducted on 60 subjects and the time to first analgesic requirement during the postoperative period  among the three groups will be compared  from postoperative period till discharge from hospital. Intra operative Fentanyl requirement, Post operative FLACC scores, Duration for performing each block and total cumulative requirement of Paracetamol and Fentanyl during post operative period till discharge from hospital will be compared as secondary outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-20
• Study Completion: 2021-05-31
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA I and II functional status.

Exclusion Criteria

refusal to give consent known allergy to local anesthetics coagulopathy infection at the injection site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time for the first demand of rescue analgesia in minutes	Time for the first demand of rescue analgesia in minutes

Secondary Outcome Measures

Name	Time	Method
1. Comparison of post operative FLACC scores.	post operative 24 hrs
2.Total cumulative Paracetamol and Fentanyl requirement in post operative period	post operative till discharge from hospital
3. Comparison of intraoperative Fentanyl requirement among the three groups	Intraoperative
4. Total duration for performance of block	intraoperative

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR; 🇮🇳 Khordha, ORISSA, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, BHUBANESWAR

🇮🇳Khordha, ORISSA, India

Dr Bikram Kishore Behera

Principal investigator

9438884047

bikrambehera007@gmail.com