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Exparel and Education to Avoid Opioids After Carpal Tunnel Release

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ClinicalTrials.gov Identifier: NCT03867539
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
American Society for Surgery of the Hand
Information provided by (Responsible Party):
Kettering Health Network

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: Differing pain management strategy Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Exparel and Education to Avoid Opioids After Carpal Tunnel Release
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
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.
Other: Differing pain management strategy
We 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.

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.
Other: Differing pain management strategy
We 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 Measures :
  1. Evaluation of post operative pain levels via Visual Analog Scale [ Time Frame: WIthin the first few months of study duration ]
    We 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 VAS and amount of pain medication taken.


Secondary Outcome Measures :
  1. Failure of alternate pain management strategy [ Time Frame: Within the first few months of study duration ]
    We aim to identify any subset of patients that do not respond to combination therapy (education + Exparel). As we cannot ignore or under treat pain, it is pertinent to uncover if there are any potential procedure, comorbid, or demographic conditions that strongly predict failure of our proposed combined therapy. Analysis of data provided by patient-answered Visual Analog Scale and amount of pain medication consumed will occur.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867539


Contacts
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Contact: Ronald Buczek, DO 937-439-6483 orthostudy2019@gmail.com

Locations
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United States, Ohio
Orthopedic Associates of Southwest Ohio Recruiting
Dayton, Ohio, United States, 45414
Contact: Laura Peterson    937-439-6483    lpeterson@oaswo.com   
Principal Investigator: Ronald Buczek, DO         
Orthopedic Associates of Southwest Ohio Recruiting
Dayton, Ohio, United States, 45459
Contact: Laura Peterson    937-439-6483      
Principal Investigator: Ronald Buczek, DO         
Sponsors and Collaborators
Kettering Health Network
American Society for Surgery of the Hand
Investigators
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Principal Investigator: Ronald Buczek, DO Kettering Health Network

Publications of Results:
Other Publications:
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Responsible Party: Kettering Health Network
ClinicalTrials.gov Identifier: NCT03867539     History of Changes
Other Study ID Numbers: 6012435
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kettering Health Network:
hand
exparel
opioid crisis
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Analgesics, Opioid
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics