QL vs LAI for Palatoplasty

Medical University of South Carolina (MUSC)

Status: Enrolling

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

Treatments: Procedure: Local anesthetic infiltration; Procedure: Quadratus lumborum block

Study type: Interventional

Funder types: Other

Identifiers

NCT06420336

Pro00136697

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Quadratus lumborum block

Active Comparator group

Description:

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.

Treatment:

Procedure: Quadratus lumborum block

Local anesthetic infiltration

Active Comparator group

Description:

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.

Treatment:

Procedure: Local anesthetic infiltration