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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
64
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.
Orthopedic Associates of Southwest Ohio
Dayton, Ohio, United States
RECRUITINGOrthopedic Associates of Southwest Ohio
Dayton, Ohio, United States
RECRUITINGEvaluation 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
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
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