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

IRB201801011

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.

2018-11-20

2024-06-30

2024-06-30

Early phase I

40

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'During the block placement the surgical team will be asked to leave the operating room briefly to remain blinded to the group assignment of all patients as the surgical team will manage the subjects post-operative care and determine discharge readiness.\n\nICU nursing staff and parents will be informed of participation in the study but will not be informed as to group assignment to remain blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-05-31