Back to results

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

Primary Purpose

Postoperative Pain, Opioid Use

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SZMN Block

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring SZMN Block, Tonsillectomy and Adenoidectomy, Regional Anesthesia

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Lucille Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SZMN Treatment Group

Control Group

Arm Description

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.

Patients in this group will receive the standard of care for T&A procedures within the pediatric population.

Outcomes

Primary Outcome Measures

Post Surgical Pain

Patients will rate their pain on a 0-10 scale

Secondary Outcome Measures

Opioid Consumption

Pain medications consumed by patients will be collected

Full Information

NCT ID

NCT04797559

First Posted

March 10, 2021

Last Updated

August 7, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04797559

Brief Title

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

Acronym

SZMN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 29, 2021 (Actual)

Primary Completion Date

April 19, 2023 (Actual)

Study Completion Date

April 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Opioid Use

Keywords

SZMN Block, Tonsillectomy and Adenoidectomy, Regional Anesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients in the interventional group will receive a total of 5 mL of local anesthetic bilaterally near their temples.

Masking

ParticipantCare Provider

Masking Description

Both groups will receive a small circular band-aid on their temples.

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SZMN Treatment Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Patients in this group will receive the standard of care for T&A procedures within the pediatric population.

Intervention Type

Procedure

Intervention Name(s)

SZMN Block

Intervention Description

Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally near the temples of the patient

Primary Outcome Measure Information:

Title

Post Surgical Pain

Description

Patients will rate their pain on a 0-10 scale

Time Frame

7 days after surgery

Secondary Outcome Measure Information:

Title

Opioid Consumption

Description

Pain medications consumed by patients will be collected

Time Frame

1-3 hours after surgery (during the patient's stay in post-anesthesia care unit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ban C Tsui, MD

Organizational Affiliation

Professor

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Carole Lin, MD

Organizational Affiliation

Pediatric Anesthesiologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lucille Packard Children's Hospital

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24525630

Citation

Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.

Results Reference

background

PubMed Identifier

18983373

Citation

Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-9. doi: 10.1111/j.1749-4486.2008.01815.x.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs