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ACTIVE NOT RECRUITING
NCT03632044
PHASE4

Evaluation of Trigeminal Nerve Blockade

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Trigeminal Nerve Blockade in the Pterygopalatine Fossa for Cleft Palate Repair: a Pilot Study

Key Details

Gender

All

Age Range

3 Months - 5 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2018-11-20

Completion Date

2027-10-30

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Ropivacaine

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

OTHER

Sham Comparator

The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.

Locations (1)

UF Health

Gainesville, Florida, United States