Post-operative PainNCT06420336
QL vs LAI for Palatoplasty
A study testing Quadratus lumborum block and Local anesthetic infiltration in people with Post-operative Pain and Opioid Use, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Post-operative Pain, Opioid Use, Cleft Palate
- What is being tested?
- Quadratus lumborum block and Local anesthetic infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Haley Nitchie, MHA, 843-792-1869, nitchie@musc.edu
About this study
Official title: 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.
- Conditions
- Post-operative Pain, Opioid Use, Cleft Palate
- Being tested
- Quadratus lumborum block, Local anesthetic infiltration
- Medical subject headings
- Pain, Postoperative, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus lumborum blockProcedure or surgery
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.
Local anesthetic infiltrationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Active comparator | 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. Receives: Procedure: Quadratus lumborum block |
| Local anesthetic infiltration | Active comparator | 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. Receives: Procedure: Local anesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
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.
Measured: 0-48 hours after surgery ends
Secondary outcomes (3)
Time to block resolution
Subjects will report the date and time that resolution of numbness over operative hip occurs or feeling of pain in operative hip returns.
Measured: up to 7 days after surgery ends
Opioid Consumption up to 48 hours after surgery ends
Total morphine milligram equivalents (MME) will be calculated from pre-op to 48-hours after surgery ends.
Measured: From the pre-operative phase up to 48 hours after surgery ends
Number of complications associated with each intervention
Complications associated with study participation will be evaluated.
Measured: From the time the intervention is administered up to 48-hours after surgery ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start25 Jun 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole McCoy, Medical University of South Carolina
- Investigators
- Nicole McCoy, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420336
- Sponsor's protocol ID
- Pro00136697
- Status last verified
- Jul 2026
- First submitted
- 14 May 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06420336
- Acronym / sponsor ID
- Pro00136697
- Conditions
- Post-operative Pain, Opioid Use, Cleft Palate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus lumborum block | Active comparator | Procedure: Quadratus lumborum blockAfter 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. |
| Local anesthetic infiltration | Active comparator | Procedure: Local anesthetic infiltrationPatient 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus lumborum blockAfter 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. | Procedure or surgery | Quadratus lumborum block |
| Local anesthetic infiltrationAfter 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. | Procedure or surgery | Local anesthetic infiltration |
Primary outcome
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.
3 secondary outcomes
Time to block resolution
Time frame: up to 7 days after surgery ends
Opioid Consumption up to 48 hours after surgery ends
Time frame: From the pre-operative phase up to 48 hours after surgery ends
Number of complications associated with each intervention
Time frame: From the time the intervention is administered up to 48-hours after surgery ends.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole McCoy, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus lumborum block and Local anesthetic infiltration in people with Post-operative Pain and Opioid Use, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Nitchie, MHA (843-792-1869, nitchie@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 0-48 hours after surgery ends). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.