| NCT ID | NCT06420336 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Post-operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 46 participants in total. It began in 2024-06-25 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Nicole McCoy, M.D.
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06420336 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Post-operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06420336 currently recruiting?
Yes, NCT06420336 is actively recruiting participants. Contact the research team at nitchie@musc.edu for enrollment information.
Where is the NCT06420336 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06420336 clinical trial?
NCT06420336 is sponsored by Medical University of South Carolina. The principal investigator is Nicole McCoy, M.D. at Medical University of South Carolina. The trial plans to enroll 46 participants.