Exparel and Education to Avoid Opioids After Carpal Tunnel Release

Study Overview
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Brief Summary
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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.

Detailed Description
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As has become apparent in the media, as well as in the clinical practice of nearly every type of medicine over the last few years, the nation is currently experiencing an opioid epidemic. This is a significant public health issue that has sweeping consequences that reach far beyond the medical field. The investigators believe over the last several decades, public perception regarding pain, especially post-operatively, has changed for the worse. The nation is in need of a paradigm shift in the way pain is managed, and the way the public perceives this issue, especially regarding pain expectations. As patients have become more involved with medical care as well as more knowledgeable, the investigators often see patients having performed online research regarding outcomes and expectations following particular procedures, to include post-operative pain. Commonly, even for smaller procedures performed in office, patients request opioids. As of yet, there are few data regarding use of long acting (Exparel) local analgesia alone in hand surgery, and none combining this strategy with pre-operative opioid education. The goal is to build the groundwork for the cessation of opioid prescription following carpal tunnel surgery, and produce proof that may be given patients to showing this to be an effective strategy. As some sources estimate 400,000 carpal tunnel surgeries are performed yearly, it is believed that this alternative pain management strategy, if adopted at a national level, would make a significant step towards remedying the current crisis. The rationale as to why this will be successful is the duration of action of Exparel, which has been shown to be effective for up to 72 hours. By 72 hours, post-procedure pain levels tend to have dropped precipitously, if not resolved. Use of pre-operative opioid education has also been shown to decrease perception of the need for and use of opioids. The investigators plan to study two groups: a control/standard of care group, that are given pre-operative opioid education as well as opioids, and a study group, which will have pre-operative opioid education, Exparel injection, and no opioids. Exparel will be administered as 10cc injected in the operative field, consisting of  5cc of Exparel,  5cc of bupivacaine, and epinephrine. All injections will be performed in the same manner. Following injection, carpal tunnel release will be performed in a similar manner in all patients. Patients that meet all of the inclusion and none of the exclusion criteria would be eligible for participation. If a patient agreed to participate, they would be randomized to group A (standard of care + education), or group B (Exparel + education + no opioids). This would be accomplished by drawing an A or B written on a paper ticket out of a bag. Adverse reactions and pain levels at 24, 48, and 72 hours will be assessed with telephone or email questionnaire, as will use of medication in the opioid group. Statistical analysis will be performed using analysis of variance, Mann-Whitney U test, and/or chi square test, as appropriate. The public health relevance of this project is to alter patient's perceived need for opioid medications post procedure, and decrease the amount of circulating opioids locally and nationally. The investigators believe this a meritorious goal, given that opioid related overdose deaths have increased eight-fold from 2012 to 2016.

Official Title
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Exparel and Education to Avoid Opioids After Carpal Tunnel Release

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: Differing pain management strategy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group; Bupivacaine + opioids<br>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. | Other: Differing pain management strategy<br>* 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.<br>|
| Experimental: Experimental Group: Exparel, no opioids<br>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. | Other: Differing pain management strategy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within the first few months of study duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within the first few months of study duration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand, exparel, opioid crisis