drugset / Trial / NCT06023329

Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

NCT06023329 ↗

Phase 4 Suspended 36 enrolled University of Minnesota
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2024-05-31
Primary completion
2027-05-01
Completion
2027-05-01

Outcome

Outcome not reported

Stopped: “The current PI is leaving the study. Study team is awaiting FDA PI change approval.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ropivacaine Other / unclassified — —