Actively Recruiting
Quadratus Lumborum Block for Pain Control in Children Undergoing Palatoplasty with Anterior Iliac Bone Graft: A Randomized Trial
Led by Medical University of South Carolina · Updated on 2025-07-04
46
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pain control methods for children aged 6 to 18 undergoing palatoplasty surgery, which includes harvesting bone from the front of the hip. The trial compares two ways of managing pain after surgery: a unilateral quadratus lumborum (QL) block performed by an anesthesiologist and local anesthetic infiltration (LAI) applied by the surgeon. The main focus is to assess post-operative pain within the first 48 hours, along with additional outcomes like pain medication use, block resolution time, and any complications related to these pain control methods. Participants will be randomly assigned to receive either the QL block or local anesthetic infiltration after anesthesia induction. For the QL block, an anesthesiologist uses ultrasound guidance to inject ropivacaine with dexamethasone near specific muscles on the side of the bone graft site. The LAI group receives the surgeon's usual local anesthetic injection at the surgical incision site. To keep the study blind, a bandage is placed where the QL block would have been for those receiving LAI. Both techniques are part of the surgical procedure and are done under anesthesia. During the study, pain scores are recorded for the first 48 hours after surgery, and researchers monitor the time it takes for the block to resolve, opioid use, and any complications within that period. The study includes preoperative preparation, surgery, and postoperative observation up to 7 days to assess block resolution. Participants are admitted after surgery as planned and undergo routine monitoring and documentation of medication and pain levels to evaluate the effectiveness and safety of the two pain control approaches.
CONDITIONS
Brief Title
QL vs LAI for Palatoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest.
- Ages 6-18 years.
- Planned admission after surgery.
- ASA physical status classification between 1 and 3.
You will not qualify if you...
- Infection at the site where the QL block needle would be inserted.
- Bleeding disorders or coagulopathies.
- Allergy to local anesthetics.
- Cognitive or developmental impairments that prevent reporting pain.
- Non-English speaking or writing patients.
- Patients or guardians unable or unwilling to give informed consent or assent.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive either a quadratus lumborum block or local anesthetic infiltration after induction of anesthesia as part of their surgery for palatoplasty with anterior iliac bone graft.
1 surgical procedure visit (in-person)
Duration - Up to 7 days after surgery
Participants are monitored for pain scores, opioid consumption, block resolution, and complications up to 48 hours and up to 7 days after surgery ends.
Approximately 2 to 3 visits (in-person)
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
Haley Nitchie, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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