Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

Phase 4

Suspended

• Conditions: Otolaryngologic Surgery
• Interventions: Drug: Saline; Drug: ropivacaine

• Registration Number: NCT06023329
• Lead Sponsor: University of Minnesota

Brief Summary

Literature on the use of superficial cervical plexus blocks for ear surgery is sparse in general, and almost non-existent in the pediatric population. Overall, literature review supports the safety of performance of this block but there is minimal published literature on its utility despite anecdotal evidence of benefit. This study, especially its prospective randomized nature will allow for expansion of the evidence for or against addition of this block to the care of pediatric patients undergoing ear surgery. The purpose of this study is to determine if SCPB plus standard practices provides superior pain control, as measured by reduced opiate consumption, compared to standard practices alone when performed on pediatric patients undergoing surgery on the ear and mastoid process.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Age: <18 years and >3 months
• Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy

Exclusion Criteria

• Preoperative opiate use within the last 30 days
• Bilateral surgery
• No English speaking caregiver
• Parental/patient refusal
• Severe preoperative respiratory compromise
• Allergy to ropivacaine
• Coagulopathy: Defined by INR&gt;1.5 or Platelet count &lt;100k
• Current Infection at site of injection
• VP Shunt on side of surgical procedure
• Pregnant patients: determined by patient history and available laboratory data. Patients will not be required to have pregnancy testing done if not otherwise indicated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Saline	-
Group1	ropivacaine	-

Primary Outcome Measures

Name	Time	Method
Opioid use	30 days post surgery	measured on a MME per kilogram

Secondary Outcome Measures

Name	Time	Method
post-operative opiate use	30 days post surgery
Pain level	30 days post surgery	Pain level will be assessed via total pain scores via either FLACC or Wong-Baker Faces, both are pain scales from 0-10, 0 being no pain and 10 being the worst pain imaginable. These scales are interchangeable and will allow both patients who can read and younger patients who cannot read to rate their pain.
Post Anesthesia Care Unit anti-emetic use	30 days post surgery	Assessed via chart review of post-operative care unit medication administration
intraoperative opiate use	30 days post surgery	Assessed via chart review of opiate administration on an MME basis
Quality of Recovery	30 days post surgery	Assessed via modified version of the quality of recovery survey. The quality of recovery scale is a validated document for assessing recovery after surgery. The study will use a modified version of this with language changed for parental assessment of Quality of recovery, but the same questions and scale are used.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States