Evaluation of Trigeminal Nerve Blockade

• Status: Enrolling by invitation
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Anesthetics; Ropivacaine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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