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Search / Trial NCT03632044

Evaluation of Trigeminal Nerve Blockade

Launched by UNIVERSITY OF FLORIDA · Aug 13, 2018

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

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 u...

Gender

ALL

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

About University Of Florida

The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.

Locations

Gainesville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Cameron R Smith, MD, PhD

Principal Investigator

University of Florida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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