Exparel and Education to Avoid Opioids After Carpal Tunnel Release

Part of paid clinical trials in Dayton, Ohio.

Sponsor
Kettering Health Network
Study ID
NCT03867539
Phase
PHASE4
Status
Recruiting
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Conditions

  • Carpal Tunnel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Differing pain management strategy — DRUG
    The investigators aim to investigate an alternative (vs "standard") pain management strategy for post operative carpal tunnel release. All drugs used are FDA approved for these indications, and no drug itself is being investigated.

Study Details

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.

Key Dates

Start date
Feb 15, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control Group; Bupivacaine + opioids
    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.
  • Experimental: Experimental Group: Exparel, no opioids
    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.

Primary Outcome Measure

Evaluation of post operative pain levels via Visual Analog Scale [ Time Frame: Within the first few months of study duration ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orthopedic Associates of Southwest OhioDaytonOhio45414
Laura Peterson
[email protected]
937-439-6483
Ronald Buczek, DO (PRINCIPAL_INVESTIGATOR)
Orthopedic Associates of Southwest OhioDaytonOhio45459
Laura Peterson
937-439-6483
Ronald Buczek, DO (PRINCIPAL_INVESTIGATOR)

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By research site
Orthopedic Associates of Southwest Ohio· Dayton, OH

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