QL vs LAI for Palatoplasty

Not Applicable

Recruiting

• Conditions: Post-operative Pain; Opioid Use; Cleft Palate

• Registration Number: NCT06420336
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Study Start: 2024-06-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-01
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Scores	0-48 hours after surgery ends	Using the Wong-Baker FACES Pain Rating Scale, patients will report their average pain from 0 hours post-op through 48-hours post-op at various intervals. In the Post-Anesthesia Recovery Unit, pain scores will be evaluated every 15 minutes as clinically able, until discharged from the PACU. On Post-Op Day 1 at 9:00 am, pains average pain score from discharge to PACU to midnight will be reported. At approximately 24-hours after surgery ends, pain scores from midnight to 23-hours post-op will be reported, then at the 48-hour post-op mark, pain scores from 24-hr post op to 48-hour post-op time will be recorded.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption up to 48 hours after surgery ends	From the pre-operative phase up to 48 hours after surgery ends	Total morphine milligram equivalents (MME) will be calculated from pre-op to 48-hours after surgery ends.
Number of complications associated with each intervention	From the time the intervention is administered up to 48-hours after surgery ends.	Complications associated with study participation will be evaluated.
Time to block resolution	up to 7 days after surgery ends	Subjects will report the date and time that resolution of numbness over operative hip occurs or feeling of pain in operative hip returns.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States