Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

Conditions

• Cleft Palate Children

Eligibility Criteria

Sex

ALL

Age

9 Months - 2 Years

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Mar 1, 2021

Status verified

May 2025

Primary completion

Jun 30, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ultrasound-guided bilateral suprazygomatic maxillary nerve block
  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.
• Active Comparator: Local anesthetic infiltration of the palate
  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.

Primary Outcome Measure

Evaluation of ultrasound-guided bilateral suprazygomatic maxillary nerve block on postoperative pain scores. [ Time Frame: 48 hours after discharge ]

Locations (1)

Find similar trials in Chicago, IL

Related Studies

• Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
  Not Yet Recruiting · Old Dominion University · Norfolk, Virginia
• Speech Intervention Via Telepractice for Children With Repaired Cleft Palate
  Not Yet Recruiting · Texas Tech University Health Sciences Center · Lubbock, Texas