SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A

Study Overview
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Brief Summary
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The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures, however, have not been studied for patients undergoing tonsillectomy and adenoidectomy (T&A) procedures. The goals of this study are to determine if SZMN block can be utilized for pain control and decrease morbidity in pediatric patients undergoing T&A.

Detailed Description
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Patients between 6 months and 18 years undergoing T&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into either the suprazygomatic maxillary nerve (SZMN) block treatment cohort or the control cohort i.e standard of care. After anesthesia induction, patients randomized into the SZMN- treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur near the temples above the cheek bones. Participants enrolled into the control group will receive standard of care with no changes to their anesthetic or surgical care. Both groups will be asked for their verbal pain scores in the PACU and we will track their opioid consumption throughout the next few days after their procedure.

Official Title
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Suprazygomatic Maxillary Nerve (SZMN) Blocks for Pain Control in Pediatric Patients Undergoing T&A: Randomized Controlled Trial ]

Conditions
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Postoperative Pain, Opioid Use

Intervention / Treatment
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* Procedure: SZMN Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 0-18 Give consent/parental consent to participate in study Patients undergoing tonsillectomy and adenoidectomy Exclusion Criteria: Participants who do not consent or have parental consent Patients who are clinically unstable or require urgent/emergent intervention Patients under age 6 months

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients in the interventional group will receive a total of 5 mL of local anesthetic bilaterally near their temples.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SZMN Treatment Group<br>Patients randomized into the SZMN-treatment group will receive a bilateral single injection SZMN block under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthestic per side. | Procedure: SZMN Block<br>* Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally near the temples of the patient<br>|
| No Intervention: Control Group<br>Patients in this group will receive the standard of care for T&A procedures within the pediatric population. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Surgical Pain | Patients will rate their pain on a 0-10 scale | 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Pain medications consumed by patients will be collected | 1-3 hours after surgery (during the patient's stay in post-anesthesia care unit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SZMN Block, Tonsillectomy and Adenoidectomy, Regional Anesthesia