Recruiting

Exparel with Education

Sponsor:

Kettering Health Network

Code:

NCT03867539

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Differing pain management strategy

Study Details

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT03867539

Start date

Feb 15, 2019

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Differing pain management strategy

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.

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 and Locations

Central contacts

Ronald Buczek, DO

937-439-6483orthostudy2019@gmail.com

Locations

Orthopedic Associates of Southwest Ohio

Recruiting

Dayton, Ohio, United States, 45414

Contacts

Laura Peterson

937-439-6483lpeterson@oaswo.com

Principal Investigator:

Ronald Buczek, DO

Orthopedic Associates of Southwest Ohio

Recruiting

Dayton, Ohio, United States, 45459

Contacts

Laura Peterson

937-439-6483

Principal Investigator:

Ronald Buczek, DO

More Information

Sponsor

Kettering Health Network

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • hand
  • exparel
  • opioid crisis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kettering Health Network on 2026-04-08.