Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

NCT04909619 | Enrolling By Invitation

• 1 other identifier: 2021-4219
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nerve Block

Outcome Measures

Primary Outcomes (2)

• Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on postoperative pain scores.

  The primary outcome for this aim will be pain scores, as determined by the Face, Legs, Activity, Crying, and Consolability scale. Minimum value is 0, maximum value is 10. Higher scores indicate more pain and therefore a worse outcome.

  48 hours after discharge

• Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on perioperative analgesia requirements.

  The primary outcome for this aim will be perioperative opioid consumption reported in morphine milligram equivalents.

  48 hours after discharge

Secondary Outcomes (3)

• Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on length of stay.

  48 hours after discharge

• Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on time to oral intake.

  48 hours after discharge

• Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on total amount of fluids consumed.

  48 hours after discharge

Study Arms (2)

Ultrasound-guided bilateral suprazygomatic maxillary nerve block

EXPERIMENTAL

Patients randomized to this arm will receive an ultrasound-guided bilateral suprazygomatic maxillary nerve block using 0.15 ml/kg of 0.2% ropivacaine per side, for a total of 0.3 ml/kg immediately after induction of general anesthesia and prior to incision. Participants will also receive local infiltration of the palate with an equivalent injection volume of 0.9% saline with 1:400,000 epinephrine at 2 ml/kg. Pediatric anesthesiologists with fellowship training in regional anesthesia will perform the nerve block. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.

Procedure: Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Local anesthetic infiltration of the palate

ACTIVE COMPARATOR

Patients randomized to this arm will receive local infiltration of the palate using 0.125% bupivacaine + 1:400,000 epinephrine at a dose of 2 ml/kg intraoperatively. Local anesthetic infiltration will be performed by one of four board-certified pediatric plastic and craniofacial surgeons during repair of the palate. Patients, parents, surgeons, and the anesthesiologist will not be blinded to the specific intervention group due to the nature of the procedures involved. Nurses and the two key personnel responsible for data collection and analysis will be blinded throughout the entirety of the study.

Procedure: Local anesthetic infiltration of the palate

Interventions

Ultrasound-guided bilateral suprazygomatic maxillary nerve block PROCEDURE

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.

Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Local anesthetic infiltration of the palate PROCEDURE

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.

Local anesthetic infiltration of the palate

Eligibility Criteria

• Age: 9 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All patients undergoing primary cleft palate repair at Ann \& Robert H. Lurie Children's Hospital of Chicago during the enrollment period. The typical child at the time of cleft palate repair is age 11 to 12 months.

You may not qualify if:

• Children with a known allergy to local anesthesia (i.e., ropivacaine or bupivacaine).
• Children with prior surgical repair of the palate.

Sponsors & Collaborators

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

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Study Officials

• Arun K Gosain, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: June 2, 2021
• Study Start: March 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)