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NOT YET RECRUITING
NCT07846761
NA

Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

Summary

This prospective, randomized, double-blinded controlled trial will investigate the effectiveness of a lateral quadratus lumborum (QL) block in 50 children aged 6-14 years undergoing iliac crest bone grafting for cleft alveolus repair. Participants will receive either a lateral QL block with bupivacaine and adrenaline or a sham skin puncture. The study will primarily assess postoperative pain at the iliac crest donor site. Secondary outcomes include pain during mobilization, pain at the alveolar surgical site, opioid consumption, time to first rescue analgesia, objective mobilization measured with activity monitors, time to hospital discharge, and adverse events. The study aims to determine whether QL block provides clinically relevant postoperative analgesia while facilitating earlier mobilization and potentially reducing hospital stay in this pediatric population.

Official title: Effectiveness of Quadratus Lumborum Block in Reducing Postoperative Pain, Enhancing Mobilization, and Shortening Hospital Stay in Children Undergoing Iliac Bone Harvest for Cleft Alveolus Repair- a Prospective Randomized Controlled Study

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-09-01

Completion Date

2028-03-01

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

PROCEDURE

Lateral quadratus lumborum block

A lateral QL blocks will be performed on the site of bone graft. An ultrasound system with a linear array transducer will be used for the QL block procedure. A sterile skin scrub will be performed before needle insertion. The ultrasound coated injection needle will be advanced until the needle tip is positioned between the aponeurosis of the transversus abdominis muscle and the pararenal fat close to the quadratus lumborum muscle. Following aspiration, 0.3 ml/kg of bupivacaine 2.5 mg/ml with adrenaline 5 mcg/ml will be injected.

PROCEDURE

Sham Block

Only a skin puncture will be performed

Locations (1)

Oslo University Hospital

Oslo, Norway