Comparing two pain management techniques for children undergoing palate surgery
Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial
This study is testing two different pain management techniques for kids aged 6-18 who are having palate surgery to see which one helps them feel less pain after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06420336 on ClinicalTrials.gov |
What this trial studies
This study involves patients aged 6-18 who are scheduled for palatoplasty surgery, which includes harvesting bone from the hip. Participants will be randomly assigned to receive either a quadratus lumborum block or local anesthetic infiltration at the surgical site. The primary focus is to evaluate post-operative pain levels within the first 48 hours after surgery, while secondary outcomes will assess pain medication usage, block resolution time, and any complications arising from the interventions. The goal is to determine which method provides better pain relief and fewer side effects.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-18 who are undergoing palatoplasty with autologous bone grafting.
Not a fit: Patients with contraindications to the pain management techniques or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children undergoing palate surgery, potentially reducing opioid use.
How similar studies have performed: Other studies have shown promising results with similar pain management approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Nicole McCoy, M.D. — Medical University of South Carolina
- Study coordinator: Haley Nitchie, MHA
- Email: nitchie@musc.edu
- Phone: 843-792-1869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.