Evaluation of Trigeminal Nerve Blockade

Phase 4

• Conditions: Birth Defect; Mouth Abnormalities; Cleft Palate
• Interventions: Drug: Ropivacaine; Other: Sham Comparator

• Registration Number: NCT03632044
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2018-08-06
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2018-11-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-10-07
• Study Completion: 2025-10-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suprazygomatic maxillary nerve blockade	Ropivacaine	A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia.
25 Gauge needle	Sham Comparator	Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected.

Primary Outcome Measures

Name	Time	Method
Change in time to oral intake following palatoplasty for cleft palate	Change from baseline (post-op) and through study completion, an average of 96 hours.	Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving time to oral intake after surgery.

Secondary Outcome Measures

Name	Time	Method
Change in amount of opioids following palatoplasty for cleft palate	Change from baseline (post-op) and through study completion, an average of 96 hours.	Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving pain control after surgery.
Change in length of hospitalization following palatoplasty for cleft palate	Change from baseline (post-op) and through study completion, an average of 96 hours.	Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving time to hospital discharge after surgery.

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States