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Local Anesthetic

Local Anesthetic + Education for Carpal Tunnel Syndrome

Phase 4
Recruiting
Led By Ronald Buczek, DO
Research Sponsored by Kettering Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18
Carpal tunnel syndrome diagnosed either by physical exam or EMG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first few months of study duration
Awards & highlights

Study Summary

This trial looks at reducing opioid use after carpal tunnel surgery by using a local anesthetic and more education.

Who is the study for?
This trial is for adults over 18 with diagnosed carpal tunnel syndrome who haven't used opioids in the last six months. It's not for those allergic to bupivacaine or Percocet, taking tricyclic antidepressants, or are pregnant or prisoners.Check my eligibility
What is being tested?
The study tests if Exparel combined with opioid education can prevent post-surgery opioid use after carpal tunnel release compared to standard treatment using non-liposomal bupivacaine plus opioids.See study design
What are the potential side effects?
Exparel may cause side effects like numbness and weakness where injected, nausea, constipation, and headache. Standard pain management might lead to typical opioid-related side effects such as drowsiness, nausea, and addiction risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with carpal tunnel syndrome.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first few months of study duration
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first few months of study duration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of post operative pain levels via Visual Analog Scale
Secondary outcome measures
Failure of alternate pain management strategy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group: Exparel, no opioidsExperimental Treatment1 Intervention
This group will receive pre-operative opioid education, Exparel injection (liposomal bupivacaine, with bupivacaine, epinephrine and bicarbonate), and would not receive a prescription for opioids. This injection will be administered as 10cc injected in the operative field, consisting of ~5cc of Exparel (liposomal bupivacaine), ~5cc of bupivacaine, and ~1cc epinephrine. Pain scores and medication usage will be tracked for three days post operatively to assess the validity and efficacy of differing pain management strategies.
Group II: Control Group; Bupivacaine + opioidsActive Control1 Intervention
This is the "standard of care" arm. This group will receive pre-operative opioid education and "standard of care", which consists of an injection of 10cc bupivacaine (plus ~1cc epinephrine and bicarbonate) into the carpal tunnel and overlying skin pre-operatively, and a post operative prescription for opioids (oxycodone/acetaminophen 5/325). Pain scores and medication usage will be tracked for three days post operatively to assess the validity and efficacy of differing pain management strategies.

Find a Location

Who is running the clinical trial?

Kettering Health NetworkLead Sponsor
19 Previous Clinical Trials
1,793 Total Patients Enrolled
1 Trials studying Carpal Tunnel Syndrome
36 Patients Enrolled for Carpal Tunnel Syndrome
American Society for Surgery of the HandOTHER
10 Previous Clinical Trials
1,017 Total Patients Enrolled
Ronald Buczek, DOPrincipal InvestigatorKettering Health Network

Media Library

Exparel (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03867539 — Phase 4
Carpal Tunnel Syndrome Research Study Groups: Experimental Group: Exparel, no opioids, Control Group; Bupivacaine + opioids
Carpal Tunnel Syndrome Clinical Trial 2023: Exparel Highlights & Side Effects. Trial Name: NCT03867539 — Phase 4
Exparel (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03867539 — Phase 4
Carpal Tunnel Syndrome Patient Testimony for trial: Trial Name: NCT03867539 — Phase 4

Frequently Asked Questions

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

Is this research endeavor still accepting participants?

"Absolutely, the information posted on clinicaltrials.gov states that this venture is actively recruiting individuals to partake in it. It was originally shared on February 15th 2019 and has since been amended at least once, lastly being edited on December 5th 2022. This trial requires 64 participants from a single medical facility."

Answered by AI

How many participants have signed up for this clinical trial?

"Affirmative. According to the records on clinicaltrials.gov, this trial was initiated in February 15th 2019 and has been actively seeking participants since then; as of December 5th 2022, 64 individuals are required for 1 location."

Answered by AI

Has the FDA certified any alternative pain management approaches?

"As this is a Phase 4 trial, meaning the treatment is already approved for use and there exists ample data supporting its safety, Differing pain management strategy was given an estimation of 3."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Orthopedic Associates of Southwest Ohio
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have had carpal tunnel release surgery on both hands in 2021. Still having problems with both hands. Nerve damage also in both hands but no help yet with the nerve damage.
PatientReceived 2+ prior treatments
~11 spots leftby Mar 2025