Status:
SUSPENDED
Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
Lead Sponsor:
University of Minnesota
Conditions:
Otolaryngologic Surgery
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Age: \<18 years and \>3 months
- Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy
Exclusion
- 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.
Key Trial Info
Start Date :
January 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06023329
Start Date
January 3 2023
End Date
May 1 2027
Last Update
May 15 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455