Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair

NCT07892963 | Not Yet Recruiting

• 1 other identifier: STUDY00001302
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cleft Lip; Cleft Palate +/- Lip; Pain Management; Wound Dehiscence, Surgical

Keywords

Nerve Block; Plastic Surgery; Craniofacial Surgery; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• 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.

  Within the first 24 hours following surgery

Secondary Outcomes (1)

• Postoperative Opioid Consumption

  Within the first 24 hours following surgery

Study Arms (2)

Standard Palatal Nerve Block

EXPERIMENTAL

Participants receive the standard palatal nerve block performed during cleft palate surgery.

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.

Procedure: Suprazygomatic Maxillary Nerve Block

Interventions

Palatal Nerve Block PROCEDURE

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.

Standard Palatal Nerve Block

Suprazygomatic Maxillary Nerve Block PROCEDURE

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.

Standard Palatal Nerve Block Plus Suprazygomatic Maxillary Nerve Block

Eligibility Criteria

• Age: 9 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead

MeSH Terms

Conditions

Cleft Lip; Agnosia; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Central Study Contacts

Logan Stratton

CONTACT

443-922-6012; lstratton@childrensnational.org

Albert Oh

CONTACT

202-713-8856

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): December 16, 2026
• Primary Completion (Estimated): December 16, 2027
• Study Completion (Estimated): December 16, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share