- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06420336
QL vs LAI for Palatoplasty
May 14, 2024 updated by: Nicole McCoy, Medical University of South Carolina
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 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haley Nitchie, MHA
- Phone Number: 843-792-1869
- Email: nitchie@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
Contact:
- Haley Nitchie, MHA
- Phone Number: 843-792-1869
- Email: nitchie@musc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Quadratus lumborum block
After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block.
Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest.
The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg.
Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles.
A 50 mm-150 mm block needle will be advanced under ultrasound guidance.
Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement.
The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis.
Injection will continue to be observed with real time US guidance.
|
After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block.
Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest.
The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg.
Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles.
A 50 mm-150 mm block needle will be advanced under ultrasound guidance.
Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement.
The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis.
Injection will continue to be observed with real time US guidance.
|
Active Comparator: Local anesthetic infiltration
Patient will undergo induction of anesthesia as deemed appropriate by the attending pediatric anesthesiologist assigned to the case.
After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation.
The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount.
At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.
|
After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation.
The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount.
At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores
Time Frame: 0-48 hours after surgery ends
|
Using the Wong-Baker FACES Pain Rating Scale, patients will report their average pain from 0 hours post-op through 48-hours post-op at various intervals.
In the Post-Anesthesia Recovery Unit, pain scores will be evaluated every 15 minutes as clinically able, until discharged from the PACU.
On Post-Op Day 1 at 9:00 am, pains average pain score from discharge to PACU to midnight will be reported.
At approximately 24-hours after surgery ends, pain scores from midnight to 23-hours post-op will be reported, then at the 48-hour post-op mark, pain scores from 24-hr post op to 48-hour post-op time will be recorded.
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0-48 hours after surgery ends
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to block resolution
Time Frame: up to 7 days after surgery ends
|
Subjects will report the date and time that resolution of numbness over operative hip occurs or feeling of pain in operative hip returns.
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up to 7 days after surgery ends
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Opioid Consumption up to 48 hours after surgery ends
Time Frame: From the pre-operative phase up to 48 hours after surgery ends
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Total morphine milligram equivalents (MME) will be calculated from pre-op to 48-hours after surgery ends.
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From the pre-operative phase up to 48 hours after surgery ends
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Number of complications associated with each intervention
Time Frame: From the time the intervention is administered up to 48-hours after surgery ends.
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Complications associated with study participation will be evaluated.
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From the time the intervention is administered up to 48-hours after surgery ends.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicole McCoy, M.D., Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
May 14, 2024
First Submitted That Met QC Criteria
May 14, 2024
First Posted (Actual)
May 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 20, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Congenital Abnormalities
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Mouth Abnormalities
- Stomatognathic System Abnormalities
- Jaw Abnormalities
- Jaw Diseases
- Maxillofacial Abnormalities
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Pain, Postoperative
- Cleft Palate
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
Other Study ID Numbers
- Pro00136697
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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