MedTrace Logo

Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

NCT04909619 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-23

No results posted yet for this study

Summary

Increased pain after cleft palate surgery is the leading cause of increased hospital length of stay, delayed oral intake, readmission, and respiratory compromise. The goal is to improve all outcomes by identifying the most effective evidenced-based method of intra-operative pain control.

Conditions

  • Cleft Palate Children

Interventions

PROCEDURE

Ultrasound-guided bilateral suprazygomatic maxillary nerve block

The maxillary nerve, V2, is purely a sensory branch of the trigeminal nerve. V2 exits the skull through the foramen rotundum and courses through the pterygopalatine fossa, a small pyramid-shaped depression located posterior to the maxilla. As the maxillary nerve exits the pterygopalatine fossa, it divides into numerous branches that supply sensation to the posterior nasal cavity, palate, sinuses, and maxilla. It is within the pterygopalatine fossa that the maxillary nerve is targeted and anesthetized during the block. With the patient in the supine position after nasotracheal intubation, a needle is inserted perpendicularly between the upper border of the zygomatic arch and posterior orbital rim until it reaches the greater wing of the sphenoid, where the needle is then retracted by a few millimeters and redirected toward the nasolabial fold until it hits the pterygopalatine fossa.

PROCEDURE

Local anesthetic infiltration of the palate

Local anesthetic infiltration of the palate during cleft palate repair is universally practiced. The benefits of local anesthetic infiltration are twofold: to provide anesthesia to the terminal branches of the nasopalatine and greater palatine nerves that are in the immediate area of the injection sites and to achieve hemostasis during closure when the medication is mixed with epinephrine. To administer local anesthetic infiltration of the palate, a 25 gauge needle is inserted next to the incision into the soft tissue. The tissue is first aspirated to determine safety of injection at that site. The medication is then injected parallel to the incision on both sides.

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Principal Investigators

  • Arun K Gosain, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909619 on ClinicalTrials.gov