Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

NCT ID: NCT06023329

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2027-05-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group1

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: DRUG

will receive SCPB with ropivacaine via regional anesthesia team

Group 2

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

will receive SCPB with saline via regional anesthesia team

Interventions

ropivacaine

will receive SCPB with ropivacaine via regional anesthesia team

Intervention Type: DRUG

Saline

will receive SCPB with saline via regional anesthesia team

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Fuller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

ANES-2023-31691

Identifier Type: -

Identifier Source: org_study_id