Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Otolaryngologic Surgery
• Intervention / Treatment: Drug: ropivacaine; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Candace Nelson; Email: nelso377@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Candace Nelson; Email: nelso377@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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>1.5 or Platelet count <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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 2	Drug: Saline; will receive SCPB with saline via regional anesthesia team
Experimental: Group1	Drug: ropivacaine; will receive SCPB with ropivacaine via regional anesthesia team

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use	measured on a MME per kilogram	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opiate use	Assessed via chart review of opiate administration on an MME basis	30 days post surgery
post-operative opiate use		30 days post surgery
Pain level	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.	30 days post surgery
Quality of Recovery	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.	30 days post surgery
Post Anesthesia Care Unit anti-emetic use	Assessed via chart review of post-operative care unit medication administration	30 days post surgery

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Benjamin Fuller, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: ANES-2023-31691

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No