Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Invitation-only

Conditions: Cleft Palate Children

Treatments: Procedure: Local anesthetic infiltration of the palate; Procedure: Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT04909619

2021-4219

Details and patient eligibility

About

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.

Full description

Cleft palate repair is associated with significant perioperative pain that may require increased depth of anesthesia intraoperatively and can interfere with oral intake and accentuate breathing difficulties postoperatively, resulting in increased length of hospital stay. Optimizing pain control in the perioperative period is essential to best practice for cleft palate repair. Infiltration of the palate with local anesthetic has long been the established mechanism for pain control to minimize intraoperative anesthetic requirement and postoperative opioid use. Suprazygomatic maxillary nerve block (SMB) administered immediately prior to cleft palate repair by anesthesiologists with fellowship training in regional anesthesia is an emerging technique for local anesthetic infiltration. The latter technique is thought to provide superior pain control due to its precise and targeted action on the nerves that innervate the palate, and because it is felt that duration of action may also be prolonged due to specific infiltration around these nerves as opposed to generalized infiltration in the palatal soft tissues. The goal of our study is to evaluate outcomes following the two routes for anesthetic infiltration during cleft palate repair. If either technique is found to be more effective or of greater duration, this can have direct impact in decreasing the need for perioperative opioid use, decreasing hospital length of stay, and less potential for airway suppression from excessive use of postoperative analgesics.

Enrollment: 40 estimated patients

Sex: All

Ages: 9 months to 2 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Experimental group

Description:

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.

Treatment:

Procedure: Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Local anesthetic infiltration of the palate

Active Comparator group

Description:

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.

Treatment:

Procedure: Local anesthetic infiltration of the palate