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Recruiting NCT06420336

QL vs LAI for Palatoplasty

No phase Interventional Post-operative Pain Opioid Use Cleft Palate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quadratus lumborum block, Local anesthetic infiltration.
Who it may be relevant to
Registry conditions: Post-operative Pain, Opioid Use, Cleft Palate. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 qu
  • Procedure 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 bl

Primary outcome measures

  • Pain Scores [Time frame: 0-48 hours after surgery ends]
Secondary outcome measures (3)
  • Time to block resolution [Time frame: up to 7 days after surgery ends]
  • Opioid Consumption up to 48 hours after surgery ends [Time frame: From the pre-operative phase up to 48 hours after surgery ends]
  • Number of complications associated with each intervention [Time frame: From the time the intervention is administered up to 48-hours after surgery ends.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT06420336 · Pro00136697

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗