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NCT Number: NCT06420336

QL vs LAI for Palatoplasty

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

quadratus lumborum block

Procedure

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

Procedure

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 outcomes

  1. Pain Scores

    Time frame: 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 outcomes

  1. Time to block resolution

    Time frame: 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.

  2. Opioid Consumption up to 48 hours after surgery ends

    Time frame: 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.

  3. Number of complications associated with each intervention

    Time frame: From the time the intervention is administered up to 48-hours after surgery ends.

    Complications associated with study participation will be evaluated.

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 20, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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