QL vs LAI for Palatoplasty

Last updated: July 11, 2024
Sponsor: Medical University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Drug Use

Treatment

Local anesthetic infiltration

Quadratus lumborum block

Clinical Study ID

NCT06420336
Pro00136697
  • Ages 6-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Local anesthetic infiltration
Phase:
Study Start date:
June 25, 2024
Estimated Completion Date:
July 30, 2026

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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