Exparel and Education to Avoid Opioids After Carpal Tunnel Release
Who is this study for? Adult patients with carpal tunnel syndrome
What treatments are being studied? Differing pain management strategy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• carpal tunnel syndrome diagnosed either by physical exam or EMG
• age \>18.
Locations
United States
Ohio
Orthopedic Associates of Southwest Ohio
RECRUITING
Dayton
Orthopedic Associates of Southwest Ohio
RECRUITING
Dayton
Contact Information
Primary
Ronald Buczek, DO
orthostudy2019@gmail.com
937-439-6483
Time Frame
Start Date: 2019-02-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 64
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: American Society for Surgery of the Hand
Leads: Kettering Health Network