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Recruiting Phase 4 NCT03867539

NCT03867539 Exparel and Education to Avoid Opioids After Carpal Tunnel Release

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Clinical Trial Summary
NCT ID NCT03867539
Status Recruiting
Phase Phase 4
Sponsor Kettering Health Network
Condition Carpal Tunnel Syndrome
Study Type INTERVENTIONAL
Enrollment 64 participants
Start Date 2019-02-15
Primary Completion 2027-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Differing pain management strategy

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 64 participants in total. It began in 2019-02-15 with a primary completion date of 2027-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This trial seeks to use the long acting local anesthetic Exparel, in conjunction with opioid education, to attempt to avoid any post-operative opioid use following carpal tunnel surgery. This group will be compared with a "standard" group that receives non-liposomal bupivacaine, opioid education, and opioids.

Eligibility Criteria

Inclusion Criteria: * carpal tunnel syndrome diagnosed either by physical exam or EMG * age \>18. Exclusion Criteria: * allergy to bupivacaine * pre-operative opioid usage within the last six months * patients allergic to Percocet or acetaminophen * patients taking tricyclic antidepressants (interaction with bupivacaine) * vulnerable populations (prisoners or pregnant women)

Contact & Investigator

Central Contact

Ronald Buczek, DO

✉ orthostudy2019@gmail.com

📞 937-439-6483

Principal Investigator

Ronald Buczek, DO

PRINCIPAL INVESTIGATOR

Kettering Health Network

Frequently Asked Questions

Who can join the NCT03867539 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Carpal Tunnel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT03867539 trial and what does that mean for participants?

Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.

Is NCT03867539 currently recruiting?

Yes, NCT03867539 is actively recruiting participants. Contact the research team at orthostudy2019@gmail.com for enrollment information.

Where is the NCT03867539 trial being conducted?

This trial is being conducted at Dayton, United States, Dayton, United States.

Who is sponsoring the NCT03867539 clinical trial?

NCT03867539 is sponsored by Kettering Health Network. The principal investigator is Ronald Buczek, DO at Kettering Health Network. The trial plans to enroll 64 participants.

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