Trials
Search / Trial NCT06420336

QL vs LAI for Palatoplasty

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · May 14, 2024

Trial Information

Current as of February 08, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to manage pain after a specific surgery called palatoplasty, which is performed on children and teens aged 6 to 18 who have a cleft palate. The goal is to see which method works better for reducing pain in the first 48 hours after surgery. One group of patients will receive a special nerve block called a QL block to help numb the area, while the other group will get a local anesthetic directly at the site of the incision. Researchers will also look at how much pain medicine the patients need, how long the numbing lasts, and if there are any complications from the treatments.

To be eligible for this trial, patients must be between 6 and 18 years old, undergoing palatoplasty with a specific bone graft procedure, and expected to stay in the hospital after surgery. Certain conditions, such as infections, bleeding disorders, or allergies to the medications used, may prevent someone from participating. If you or your child joins the study, you can expect to receive either pain management method and be monitored closely for any side effects or complications during the recovery period.

Gender

ALL

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.

Trial Officials

Nicole McCoy, M.D.

Principal Investigator

Medical University of South Carolina

About Medical University Of South Carolina

The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.

Locations

Charleston, South Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0