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Clinical Trials/CTRI/2025/09/094973
CTRI/2025/09/094973
Not yet recruiting
Phase 2

Comparison of Post Operative Analgesic Efficacy of Quadratus Lumborum Block With Bupivacaine of Same Dose and Different Concentrations in Paediatric Patients Undergoing Unilateral Open Inguinal Hernia Repair

VMMC and Safdarjung Hospital1 site in 1 country76 target enrollmentStarted: October 1, 2025Last updated:

Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
VMMC and Safdarjung Hospital
Enrollment
76
Locations
1
Primary Endpoint
To compare post operative analgesic efficacy of Quadratus lumborum block with bupivacaine

Overview

Brief Summary

This study is a prospective, interventional trial designed to assess the effectiveness of ultrasound-guided Quadratus Lumborum Block (QLB) for postoperative pain relief in children aged 1 to 7 years undergoing unilateral open inguinal hernia surgery. The research compares two groups receiving the same total dose of bupivacaine (0.75 mg/kg) but at different concentrations and volumes: Group A receives 0.3 ml/kg of 0.25% bupivacaine, while Group B receives 0.6 ml/kg of 0.125% bupivacaine. The primary outcome is pain score measured using the CHEOPS scale at 6 hours post-surgery. Secondary outcomes include pain scores at additional time intervals, time to first rescue analgesia, total analgesic consumption over 24 hours, and intraoperative fentanyl usage. The goal is to determine whether a lower concentration with higher volume offers pain relief comparable to a higher concentration with lower volume, while remaining within safe limits for pediatric patients.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
1.00 Year(s) to 7.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged 1 – 7 years with American Society of Anesthesiologists physical status I-II scheduled for unilateral open inguinal hernia surgery.

Exclusion Criteria

  • EXCLUSION CRITERIA
  • Infection at the site of block
  • Coagulopathy
  • Pre-existing neurological disease
  • Allergy to local anesthetics.

Outcomes

Primary Outcomes

To compare post operative analgesic efficacy of Quadratus lumborum block with bupivacaine

Time Frame: CHEOPS score at 6 hours.

of same dose and different concentrations in paediatric patients undergoing open inguinal

Time Frame: CHEOPS score at 6 hours.

hernia repair using the CHEOPS score at 6 hours.

Time Frame: CHEOPS score at 6 hours.

Secondary Outcomes

  • 1.To compare CHEOPS score at 0,3,8,18 and 24 hours.(2.To compare time to first rescue analgesia)

Investigators

Sponsor
VMMC and Safdarjung Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Mayank Singh

VMMC and Safdarjung Hopital

Study Sites (1)

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