Evaluation of Trigeminal Nerve Blockade

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2027-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mouth Abnormalities Cleft Palate Birth Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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Suprazygomatic maxillary nerve blockade

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.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type 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

25 Gauge needle

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

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

Sham Comparator

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

Intervention Type OTHER

Other Intervention Names

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Naropin Control

Eligibility Criteria

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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

Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No