Nerve Block for Pediatric ENT Surgery
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used opiates in the last 30 days.
What data supports the effectiveness of the treatment Superficial Cervical Plexus Block (SCPB) for pediatric ENT surgery?
Research shows that the Superficial Cervical Plexus Block (SCPB) is effective in providing pain relief for various head and neck surgeries, reducing the need for additional pain medication and improving recovery quality. It has been successfully used in surgeries involving the neck and jaw areas, suggesting it could be beneficial for pediatric ENT surgeries as well.12345
Is the superficial cervical plexus block (SCPB) generally safe for use in humans?
How does the nerve block treatment for pediatric ENT surgery differ from other treatments?
The nerve block treatment, specifically the superficial cervical plexus block (SCPB), is unique because it uses ultrasound guidance to target specific nerves in the neck region, providing localized pain relief without the need for general anesthesia. This approach can reduce the risks and recovery time associated with general anesthesia, making it a potentially safer option for children undergoing ENT surgery.23678
What is the purpose of this trial?
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.
Research Team
Benjamin Fuller, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
This trial is for children older than 3 months and under 18 years who are having specific ear surgeries (like cochlear implant or tympanomastoidectomy). They can't join if they've used opiates recently, have severe breathing issues, are allergic to ropivacaine, need bilateral surgery, don't have an English-speaking caregiver, refuse to participate, have bleeding disorders or infections at the injection site.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery with or without the superficial cervical plexus block
Follow-up
Participants are monitored for safety and effectiveness after treatment, including opioid use and recovery quality
Treatment Details
Interventions
- Superficial Cervical Plexus Block
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor