Evaluation of Trigeminal Nerve Blockade



Status:Enrolling by invitation
Conditions:Women's Studies, Cosmetic
Therapuetic Areas:Dermatology / Plastic Surgery, Reproductive
Healthy:No
Age Range:Any - 5
Updated:1/2/2019
Start Date:November 20, 2018
End Date:December 2020

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

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.

Cleft palate is a common congenital anomaly for which surgical repair is indicated during
early childhood. The surgical repair of cleft palate is very painful, and generally requires
high doses of opioids for adequate pain control, placing children at risk for post-operative
respiratory depression and airway obstruction. An alternative approach to post-operative
analgesia for cleft palate repair is the placement of nerve blocks in the pterygopalatine
fossa bilaterally, blocking the maxillary nerve and covering the entire mid-face. This
randomized, double-blinded study will investigate the utility of maxillary nerve blockade in
controlling post-operative pain, decreasing opioid requirements, improving post-operative
oral food and drink intake, and decreasing hospital length-of-stay after cleft palate repair.

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
We found this trial at
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Gainesville, Florida 32608
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Gainesville, FL
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