Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

NCT06023329 | Suspended Phase 4 FDA Drug

• 1 other identifier: ANES-2023-31691
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Otolaryngologic Surgery

Outcome Measures

Primary Outcomes (1)

• Opioid use

  measured on a MME per kilogram

  30 days post surgery

Secondary Outcomes (5)

• intraoperative opiate use

  30 days post surgery

• post-operative opiate use

  30 days post surgery

• Pain level

  30 days post surgery

• Quality of Recovery

  30 days post surgery

• Post Anesthesia Care Unit anti-emetic use

  30 days post surgery

Study Arms (2)

Group1

EXPERIMENTAL

Drug: ropivacaine

Group 2

PLACEBO COMPARATOR

Drug: Saline

Interventions

ropivacaine DRUG

will receive SCPB with ropivacaine via regional anesthesia team

Group1

Saline DRUG

will receive SCPB with saline via regional anesthesia team

Group 2

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Benjamin Fuller, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 5, 2023
• Study Start: January 3, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)