Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes
Cleft Palate Children
About this trial
This is an interventional treatment trial for Cleft Palate Children focused on measuring Nerve Block
Eligibility Criteria
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.
Sites / Locations
- Ann & Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ultrasound-guided bilateral suprazygomatic maxillary nerve block
Local anesthetic infiltration of the palate
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.
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.