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Nerve Block for Pediatric ENT Surgery

Phase 4

Recruiting

Led By Benjamin Fuller, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: <18 years and >3 months

Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post surgery

Awards & highlights

Study Summary

This trial is studying if using a nerve block and standard practices for ear surgery in kids reduces pain and need for opioids.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests whether a superficial cervical plexus block with ropivacaine plus standard care provides better pain control compared to just standard care in kids having ear surgery. It's a randomized trial which means patients will be randomly assigned to receive either the block with ropivacaine or saline as a comparison.See study design

What are the potential side effects?

Possible side effects from the ropivacaine may include reactions at the injection site like swelling or pain, nerve damage symptoms such as weakness or numbness around the neck and shoulders area. However, these side effects are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 3 months but younger than 18 years.

Select...

I have had surgery for a cochlear implant or to treat an ear condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid use

Secondary outcome measures

Pain level

Post Anesthesia Care Unit anti-emetic use

Quality of Recovery

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group1Experimental Treatment1 Intervention

Group II: Group 2Placebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ropivacaine

2011

Completed Phase 4

~1750

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,939 Total Patients Enrolled

Benjamin Fuller, MDPrincipal InvestigatorUniversity of Minnesota

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this research incorporate individuals younger than 60?

"This research protocol is open to paediatric patients aged between 3 months and 18 years old."

Answered by AI

Is there an opportunity for me to partake in the clinical trial?

"The criteria for eligibility specifies that those between 3 months and 18 years of age who have undergone ENT surgery can apply. Up to 36 individuals will be selected in total."

Answered by AI

To what degree does Group1 pose a risk to individuals?

"The safety of Group1 is rated at 3 due to its Phase 4 status, which denotes the approval of this medication."

Answered by AI

Is this clinical trial currently open to participants?

"According to clinicaltrials.gov, the recruitment for this medical trial has ended as of August 28th 2023 and is no longer accepting any new candidates. However, other studies are still in progress and inviting participants to join their research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery

2023. "Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023329.