Cleft LipNCT07892963
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
A study testing Palatal Nerve Block and Suprazygomatic Maxillary Nerve Block in people with Cleft Lip and Cleft Palate +/- Lip, run by Children's National Research Institute.
Trial summary
This study will evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children. Read more about this study
- Who is it for?
- Ages 9 months and older
- Conditions the study is for
- Cleft Lip, Cleft Palate +/- Lip, Pain Management
- What is being tested?
- Palatal Nerve Block and Suprazygomatic Maxillary Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2026to 16 Dec 2028
- 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 9 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children undergoing primary cleft palate repair or secondary velopharyngeal insufficiency (VPI) surgery.
- Eligible to receive regional anesthetic nerve blocks as part of the planned surgical procedure.
- Parent or legal guardian able and willing to provide informed consent.
- Participant meets all institutional and surgical criteria for undergoing the planned procedure.
Who cannot join
- Known allergy, hypersensitivity, or contraindication to the study anesthetic medications.
- Medical conditions that contraindicate regional anesthetic nerve block procedures.
- Coagulopathy or bleeding disorder that would increase the risk of nerve block placement.
- Active infection at or near the planned injection site.
- Inability of parent or legal guardian to provide informed consent.
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Albert Oh contact
About this study
This study will evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children. Participants will be randomly assigned to receive either the standard palatal block alone or the standard palatal block combined with a suprazygomatic maxillary nerve block. Both techniques use medications commonly used for pain management during surgery.
The purpose of this study is to determine whether the addition of the suprazygomatic maxillary nerve block reduces postoperative pain, decreases the need for opioid medications, and improves recovery after cleft palate repair. Researchers will compare pain scores, medication use, recovery outcomes, and any treatment-related complications between the two groups.
Information collected from this study may help identify the most effective regional anesthesia approach for children undergoing cleft palate repair and may improve postoperative pain management and patient recovery.
- Being tested
- Palatal Nerve Block, Suprazygomatic Maxillary Nerve Block
- Keywords
- Nerve Block, Plastic Surgery, Craniofacial Surgery, Anesthesiology
- Medical subject headings
- Cleft Lip, Agnosia, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal Nerve BlockProcedure or surgery
Regional anesthetic block of the palate performed during cleft palate or velopharyngeal insufficiency surgery using local anesthetic. This procedure serves as the standard pain management approach and is intended to provide perioperative analgesia and reduce postoperative pain.
Suprazygomatic Maxillary Nerve BlockProcedure or surgery
Regional anesthetic block of the maxillary nerve performed via a suprazygomatic approach using local anesthetic in addition to the standard palatal nerve block. The procedure is intended to enhance perioperative analgesia, decrease postoperative pain, and reduce postoperative opioid requirements following cleft palate or velopharyngeal insufficiency surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard Palatal Nerve Block | Experimental | Participants receive the standard palatal nerve block performed during cleft palate surgery. Receives: Procedure: Palatal Nerve Block |
| Standard Palatal Nerve Block Plus Suprazygomatic Maxillary Nerve Block | Experimental | Participants receive the standard palatal nerve block plus a suprazygomatic maxillary nerve block during cleft palate surgery. Receives: Procedure: Suprazygomatic Maxillary Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
Postoperative pain will be assessed using age-appropriate validated pain scales following cleft palate repair or velopharyngeal insufficiency surgery. Pain scores will be compared between participants receiving a standard palatal nerve block and those receiving a standard palatal nerve block plus a suprazygomatic maxillary nerve block to evaluate the effectiveness of the additional regional anesthesia technique.
Measured: Within the first 24 hours following surgery
Secondary outcomes (1)
Postoperative Opioid Consumption
Total postoperative opioid medication use will be recorded and compared between participants receiving a standard palatal nerve block and those receiving a standard palatal nerve block plus a suprazygomatic maxillary nerve block. This outcome will assess whether the additional regional anesthesia technique reduces the need for opioid analgesics following surgery.
Measured: Within the first 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start16 Dec 2026 (estimated)
- Primary completion16 Dec 2027 (estimated)
- Study completion16 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892963
- Sponsor's protocol ID
- STUDY00001302
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with researchers outside of the study team. Data collected for this study contain protected health information and were obtained under informed consent and institutional review board requirements that do not include plans for external sharing of individual participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
- ClinicalTrials.gov ID
- NCT07892963
- Acronym / sponsor ID
- STUDY00001302
- Keywords
- Nerve Block, Plastic Surgery, Craniofacial Surgery, Anesthesiology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 16 Dec 2026 (estimated)
- Primary completion
- 16 Dec 2027 (estimated)
- Study completion
- 16 Dec 2028 (estimated)
- First posted
- 23 Oct 2026 (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 evaluate whether adding a suprazygomatic maxillary nerve block to the standard palatal nerve block improves pain control after cleft palate repair surgery in children. Participants will be randomly assigned to receive either the standard palatal block alone or the standard palatal block combined with a suprazygomatic maxillary nerve block. Both techniques use medications commonly used for pain management during surgery.
The purpose of this study is to determine whether the addition of the suprazygomatic maxillary nerve block reduces postoperative pain, decreases the need for opioid medications, and improves recovery after cleft palate repair. Researchers will compare pain scores, medication use, recovery outcomes, and any treatment-related complications between the two groups.
Information collected from this study may help identify the most effective regional anesthesia approach for children undergoing cleft palate repair and may improve postoperative pain management and patient recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Palatal Nerve Block | Experimental | Procedure: Palatal Nerve BlockParticipants receive the standard palatal nerve block performed during cleft palate surgery. |
| Standard Palatal Nerve Block Plus Suprazygomatic Maxillary Nerve Block | Experimental | Procedure: Suprazygomatic Maxillary Nerve BlockParticipants receive the standard palatal nerve block plus a suprazygomatic maxillary nerve block during cleft palate surgery. |
Who may qualify
- Ages
- 9 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children undergoing primary cleft palate repair or secondary velopharyngeal insufficiency (VPI) surgery.
- Eligible to receive regional anesthetic nerve blocks as part of the planned surgical procedure.
- Parent or legal guardian able and willing to provide informed consent.
- Participant meets all institutional and surgical criteria for undergoing the planned procedure.
Key exclusion criteria (6 listed)
- Known allergy, hypersensitivity, or contraindication to the study anesthetic medications.
- Medical conditions that contraindicate regional anesthetic nerve block procedures.
- Coagulopathy or bleeding disorder that would increase the risk of nerve block placement.
- Active infection at or near the planned injection site.
- Inability of parent or legal guardian to provide informed consent.
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 |
|---|---|---|
| Palatal Nerve BlockRegional anesthetic block of the palate performed during cleft palate or velopharyngeal insufficiency surgery using local anesthetic. This procedure serves as the standard pain management approach and is intended to provide perioperative analgesia and reduce postoperative pain. | Procedure or surgery | Standard Palatal Nerve Block |
| Suprazygomatic Maxillary Nerve BlockRegional anesthetic block of the maxillary nerve performed via a suprazygomatic approach using local anesthetic in addition to the standard palatal nerve block. The procedure is intended to enhance perioperative analgesia, decrease postoperative pain, and reduce postoperative opioid requirements following cleft palate or velopharyngeal insufficiency surgery. | Procedure or surgery | Standard Palatal Nerve Block Plus Suprazygomatic Maxillary Nerve Block |
Primary outcome
Postoperative Pain Scores
Time frame: Within the first 24 hours following surgery
Postoperative pain will be assessed using age-appropriate validated pain scales following cleft palate repair or velopharyngeal insufficiency surgery. Pain scores will be compared between participants receiving a standard palatal nerve block and those receiving a standard palatal nerve block plus a suprazygomatic maxillary nerve block to evaluate the effectiveness of the additional regional anesthesia technique.
1 secondary outcome
Postoperative Opioid Consumption
Time frame: Within the first 24 hours following surgery
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 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers outside of the study team. Data collected for this study contain protected health information and were obtained under informed consent and institutional review board requirements that do not include plans for external sharing of individual participant-level data.
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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.
Albert Oh contact
Questions about this trial
What is this clinical trial studying?
A study testing Palatal Nerve Block and Suprazygomatic Maxillary Nerve Block in people with Cleft Lip and Cleft Palate +/- Lip, run by Children's National Research Institute.
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 6 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Logan Stratton (443-922-6012, lstratton@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores (time frame: Within the first 24 hours following surgery). 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 23 Oct 2026.