Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes: Can we Minimize Analgesic and Opioid Use?

Status: Enrolling by invitation
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9 months
Maximum Age: 2
Healthy Volunteers: Accepts Healthy Volunteers
View:

• 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.

Locations
United States
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Time Frame
Start Date: March 1, 2021
Estimated Completion Date: December 31, 2021
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Leads: Ann & Robert H Lurie Children's Hospital of Chicago

This content was sourced from clinicaltrials.gov

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