Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery (NCT06023329) | Clinical Trial Compass
SuspendedPhase 4
Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery
Stopped: The current PI is leaving the study. Study team is awaiting FDA PI change approval.
United States36 participantsStarted 2024-05-31
Plain-language 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.
Who can participate
Age range
3 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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\>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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.