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Evaluation of Trigeminal Nerve Blockade

Primary Purpose

Mouth Abnormalities, Cleft Palate, Birth Defect

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Sham Comparator
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mouth Abnormalities

Eligibility Criteria

3 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Suprazygomatic maxillary nerve blockade

25 Gauge needle

Arm Description

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.

Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in amount of opioids 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 pain control after surgery.
Change in length of hospitalization 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 hospital discharge after surgery.

Full Information

First Posted
August 6, 2018
Last Updated
September 7, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03632044
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth Abnormalities, Cleft Palate, Birth Defect

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suprazygomatic maxillary nerve blockade
Arm Type
Experimental
Arm Description
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.
Arm Title
25 Gauge needle
Arm Type
Sham Comparator
Arm Description
Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Other Intervention Name(s)
Control
Intervention Description
The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.
Primary Outcome Measure Information:
Title
Change in time to oral intake following palatoplasty for cleft palate
Description
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.
Time Frame
Change from baseline (post-op) and through study completion, an average of 96 hours.
Secondary Outcome Measure Information:
Title
Change in amount of opioids following palatoplasty for cleft palate
Description
Application of bilateral suprazygomatic maxillary nerve blockade of the infraorbital nerve to provide effective analgesia for cleft lip repair, improving pain control after surgery.
Time Frame
Change from baseline (post-op) and through study completion, an average of 96 hours.
Title
Change in length of hospitalization following palatoplasty for cleft palate
Description
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.
Time Frame
Change from baseline (post-op) and through study completion, an average of 96 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron R Smith, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-3003
Country
United States

12. IPD Sharing Statement

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Evaluation of Trigeminal Nerve Blockade

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