Evaluation of Trigeminal Nerve Blockade

Study Overview
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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.

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.

Official Title
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Evaluation of Trigeminal Nerve Blockade in the Pterygopalatine Fossa for Cleft Palate Repair: a Pilot Study

Conditions
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Mouth Abnormalities, Cleft Palate, Birth Defect

Intervention / Treatment
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* Drug: Ropivacaine
* Other: Sham Comparator


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprazygomatic maxillary nerve blockade<br>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<br>* 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<br>* Other names: Naropin;|
| Sham Comparator: 25 Gauge needle<br>Subcutaneous placement of a 25 Gauge needle as a sham comparator after the induction of general anesthesia. Nothing will be injected. | Other: Sham Comparator<br>* The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 from baseline (post-op) and through study completion, an average of 96 hours. | 
| 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. | Change from baseline (post-op) and through study completion, an average of 96 hours. |