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

NCT04797559 | Completed

• 1 other identifier: 60450
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Opioid Use

Keywords

SZMN Block; Tonsillectomy and Adenoidectomy; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• Post Surgical Pain

  Patients will rate their pain on a 0-10 scale

  7 days after surgery

Secondary Outcomes (1)

• Opioid Consumption

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

Study Arms (2)

SZMN Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

SZMN Block PROCEDURE

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

SZMN Treatment Group

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participants who do not consent or have parental consent
• Patients who are clinically unstable or require urgent/emergent intervention
• Patients under age 6 months

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (3)

• 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.

  PMID: 24525630 BACKGROUND

• 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.

  PMID: 18983373 RESULT

• Lin C, Abboud S, Zoghbi V, Kasimova K, Thein J, Meister KD, Sidell DR, Balakrishnan K, Tsui BCH. Suprazygomatic Maxillary Nerve Blocks and Opioid Requirements in Pediatric Adenotonsillectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):564-571. doi: 10.1001/jamaoto.2024.1011.

  PMID: 38780948 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ban C Tsui, MD

  Professor

  STUDY DIRECTOR

• Carole Lin, MD

  Pediatric Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both groups will receive a small circular band-aid on their temples.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: November 29, 2021
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)