QL vs LAI for Palatoplasty

Opioid Use Clinical Trial

Official title:

Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420336
• Other study ID #: Pro00136697
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 30, 2026

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Haley Nitchie, MHA
• Phone: 843-792-1869
• Email: nitchie[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: July 30, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria

• Patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest.

• Ages 6-18 years of age

• Planned admission post-op

• ASA Status Range: 1-3

Exclusion Criteria

• Contraindication to QL blocks or LAI which may include:

• overlying infection skin at the block needle insertion site

• coagulopathies

• known bleeding disorders

• Allergy to local anesthetic

• Cognitive or developmental impairment that would limit ability to report pain.

• Non-English Speaking/Writing

• Subjects or their parent/guardian unable or choose to not give informed consent/assent.

Related Conditions & MeSH terms

• Cleft Palate
• Opioid Use
• Pain, Postoperative
• Post-operative Pain

Intervention

Procedure:
• 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
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	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.	0-48 hours after surgery ends
Secondary	Time to block resolution	Subjects will report the date and time that resolution of numbness over operative hip occurs or feeling of pain in operative hip returns.	up to 7 days after surgery ends
Secondary	Opioid Consumption up to 48 hours after surgery ends	Total morphine milligram equivalents (MME) will be calculated from pre-op to 48-hours after surgery ends.	From the pre-operative phase up to 48 hours after surgery ends
Secondary	Number of complications associated with each intervention	Complications associated with study participation will be evaluated.	From the time the intervention is administered up to 48-hours after surgery ends.