Exparel and Education to Avoid Opioids After Carpal Tunnel Release

ConditionCarpal Tunnel Syndrome

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorKettering Health Network

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

carpal tunnel syndrome diagnosed either by physical exam or EMG

age >18.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Control Group; Bupivacaine + opioidsActive comparator 1 intervention

Group B: Experimental Group: Exparel, no opioidsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Evaluation of post operative pain levels via Visual Analog Scale

The investigators aim to evaluate pain in either arm of the study, followed over a three day course. As several studies have shown pain to be wholly or mostly resolved by post-operative day three. Patients will answer questionnaire to include Visual Analog Scale for pain, and amount of pain medication taken. The Visual Analog Scale for pain ranges from a score of 0 to 10, with 0 being "no pain", 5 being "distressing pain", and 10 being "the worst pain imaginable"

Time frame

Within the first few months of study duration

Secondary outcomes

Failure of alternate pain management strategy

The investigators aim to identify any subset of patients that do not respond to combination therapy (education + Exparel). Analysis of data provided by patient-answered Visual Analog Scale will occur. Failures will be presented as a whole number and as percentage of total participants.

Time frame

Within the first few months of study duration

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kettering Health Network

Lead sponsor

American Society for Surgery of the Hand

Collaborator

Source ClinicalTrials.gov

Apply now