Nerve Block for Cleft Palate Surgery

Age: < 18

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Allergy to local anesthesia, prior palate surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Arun K Gosain, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for children around 11 to 12 months old undergoing primary cleft palate repair at Ann & Robert H. Lurie Children's Hospital of Chicago during the study period.

Inclusion Criteria

My child is having cleft palate repair at Lurie Children's Hospital.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cleft palate repair with either local anesthetic infiltration or ultrasound-guided bilateral suprazygomatic maxillary nerve block

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores, perioperative analgesia requirements, and other outcomes

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Local anesthetic infiltration of the palate
• Ultrasound-guided bilateral suprazygomatic maxillary nerve block

Trial Overview The study compares two pain control methods during cleft palate surgery: local anesthetic infiltration of the palate and ultrasound-guided bilateral suprazygomatic maxillary nerve block, aiming to improve postoperative outcomes.

Participant Groups

Group I: Ultrasound-guided bilateral suprazygomatic maxillary nerve block Experimental Treatment 1 Intervention

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.

Group II: Local anesthetic infiltration of the palate Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+