Evaluation of Trigeminal Nerve Blockade

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Mouth Abnormalities, Cleft Palate, Birth Defect

In brief

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.

Key facts

Study ID: NCT03632044
Run by: University of Florida
People needed: 40
Starts: 2018-11-20
Expected to finish: 2027-10-30
Last updated by the study team: 2026-07-21

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient presenting for palatoplasty for cleft palate only.
Parent/guardian consents to participate
Normal oral food and water intake before surgery
No underlying chronic pain condition

You may not qualify if…

Parent/guardian refuses to consent
Patient requires revision surgery on the palate
Patient requires surgery in addition to palatoplasty, including, but not limited to pharyngeal flap or soft palate lengthening procedures.
Any underlying chronic pain condition
Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
History of Pierre Robin sequence
Planned or anticipated need for any type of artificial airway post-op

Where it is running

UF Health — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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