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

Not Applicable

Completed

• Conditions: Postoperative Pain; Opioid Use
• Interventions: Procedure: SZMN Block

• Registration Number: NCT04797559
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Study Start: 2021-11-29
• Primary Completion: 2023-04-19
• Study Completion: 2023-04-19
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Ages 0-18
• Give consent/parental consent to participate in study
• Patients undergoing tonsillectomy and adenoidectomy

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SZMN Treatment Group	SZMN Block	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.

Primary Outcome Measures

Name	Time	Method
Post Surgical Pain	7 days after surgery	Patients will rate their pain on a 0-10 scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States