Clinical trial NCT03632044: Evaluation of Trigeminal Nerve Blockade
Official title: Evaluation of Trigeminal Nerve Blockade in the Pterygopalatine Fossa for Cleft Palate Repair: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Mouth Abnormalities
Cleft Palate
Birth Defect
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized, double-blinded study. Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur following consent. Randomization will be 1:1.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Change in time to oral intake following palatoplasty for cleft palate
timeFrame: Change from baseline (post-op) and through study completion, an average of 96 hours.
Secondary outcomes:
measure: Change in amount of opioids following palatoplasty for cleft palate
timeFrame: Change from baseline (post-op) and through study completion, an average of 96 hours.
measure: Change in length of hospitalization following palatoplasty for cleft palate
timeFrame: Change from baseline (post-op) and through study completion, an average of 96 hours.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Cameron R Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: