QL vs LAI for Palatoplasty

Not Applicable

Recruiting

• Conditions: Post-operative Pain; Opioid Use; Cleft Palate
• Interventions: Procedure: Quadratus lumborum block; Procedure: Local anesthetic infiltration

• 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: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-15
• 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

Arm && Interventions

Group	Intervention	Description
Quadratus lumborum block	Quadratus lumborum block	After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance.
Local anesthetic infiltration	Local anesthetic infiltration	Patient will undergo induction of anesthesia as deemed appropriate by the attending pediatric anesthesiologist assigned to the case. After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.

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