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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within the first few months of study duration

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluation of post operative pain levels via Visual Analog Scale

Secondary study objectives

Failure of alternate pain management strategy

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 3Eligibility criteria met