Evaluation of Trigeminal Nerve Blockade

NCT03632044 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: IRB201801011OCR18511
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mouth Abnormalities; Cleft Palate; Birth Defect

Outcome Measures

Primary Outcomes (1)

• Change in time to oral intake following palatoplasty for cleft palate

  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.

  Change from baseline (post-op) and through study completion, an average of 96 hours.

Secondary Outcomes (2)

• Change in amount of opioids following palatoplasty for cleft palate

  Change from baseline (post-op) and through study completion, an average of 96 hours.

• Change in length of hospitalization following palatoplasty for cleft palate

  Change from baseline (post-op) and through study completion, an average of 96 hours.

Study Arms (2)

Suprazygomatic maxillary nerve blockade

EXPERIMENTAL

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.

Drug: Ropivacaine

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.

Other: Sham Comparator

Interventions

Ropivacaine DRUG

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

Also known as: Naropin

Suprazygomatic maxillary nerve blockade

Sham Comparator OTHER

The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.

Also known as: Control

25 Gauge needle

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610-3003, United States

Location

MeSH Terms

Conditions

Mouth Abnormalities; Cleft Palate; Congenital Abnormalities

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Cameron R Smith, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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. ICU nursing staff and parents will be informed of participation in the study but will not be informed as to group assignment to remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 15, 2018
• Study Start: November 20, 2018
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-11

Locations

US (1)