Nerve Block for Cleft Palate Pain Control

Recruiting in Palo Alto (17 mi)

Overseen byCameron Smith, MD, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Cleft palate repair requires high doses of opioids for pain control postop. An alternative approach is placement of nerve blocks in the pterygopalatine fossa bilaterally, blocking the maxillary nerve \& covering the entire midface. Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve may provide effective analgesia for cleft lip repair, improving time to oral intake, pain control and time to hospital discharge.

Research Team

Cameron Smith, MD, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for children needing surgery to repair a cleft palate, who can eat and drink normally before the operation, and don't have chronic pain conditions. It's not for those needing additional surgeries beyond palatoplasty or with factors that make nerve block placement or research participation risky as judged by the study team.

Inclusion Criteria

I am having surgery to repair a cleft palate only.

Parent/guardian consents to participate

Normal oral food and water intake before surgery

See 1 more

Exclusion Criteria

I need surgery for my palate that may include other procedures to help with my speech.

Parent/guardian refuses to consent

I need a second surgery on my palate.

See 5 more

Treatment Details

Interventions

Ropivacaine (Local Anesthetic)
Sham Comparator (Other)

Trial OverviewThe study tests if blocking nerves near the midface with Ropivacaine provides better post-surgery pain relief compared to a sham treatment. The goal is to see if this method improves recovery time, reduces pain more effectively, and allows quicker return to normal eating which may lead to an earlier hospital discharge.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Suprazygomatic maxillary nerve blockadeExperimental Treatment1 Intervention

A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia.

Group II: 25 Gauge needlePlacebo Group1 Intervention

Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected.

Ropivacaine is already approved in Canada, China for the following indications: