Clinical trial NCT04797559: SZMN Blocks for Pain Control in Pediatric Patients Undergoing T&A
Official title: Suprazygomatic Maxillary Nerve (SZMN) Blocks for Pain Control in Pediatric Patients Undergoing T&A: Randomized Controlled Trial ]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Opioid Use
Keywords: SZMN Block
Tonsillectomy and Adenoidectomy
Regional Anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients in the interventional group will receive a total of 5 mL of local anesthetic bilaterally near their temples.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post Surgical Pain
timeFrame: 7 days after surgery
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 1-3 hours after surgery (during the patient's stay in post-anesthesia care unit)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Professor
name: Ban C Tsui, MD
role: STUDY_DIRECTOR
affiliation: Pediatric Anesthesiologist
name: Carole Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.