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Exparel and Education to Avoid Opioids After Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Differing pain management strategy
Sponsored by
Kettering Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carpal Tunnel Syndrome focused on measuring hand, exparel, opioid crisis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Orthopedic Associates of Southwest OhioRecruiting
  • Orthopedic Associates of Southwest OhioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group; Bupivacaine + opioids

Experimental Group: Exparel, no opioids

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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.

Full Information

First Posted
January 30, 2019
Last Updated
March 8, 2023
Sponsor
Kettering Health Network
Collaborators
American Society for Surgery of the Hand
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1. Study Identification

Unique Protocol Identification Number
NCT03867539
Brief Title
Exparel and Education to Avoid Opioids After Carpal Tunnel Release
Official Title
Exparel and Education to Avoid Opioids After Carpal Tunnel Release
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kettering Health Network
Collaborators
American Society for Surgery of the Hand

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
hand, exparel, opioid crisis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group; Bupivacaine + opioids
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Group: Exparel, no opioids
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Differing pain management strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of post operative pain levels via Visual Analog Scale
Description
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 Outcome Measure Information:
Title
Failure of alternate pain management strategy
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Buczek, DO
Phone
937-439-6483
Email
orthostudy2019@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Buczek, DO
Organizational Affiliation
Kettering Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Associates of Southwest Ohio
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Peterson
Phone
937-439-6483
Email
lpeterson@oaswo.com
First Name & Middle Initial & Last Name & Degree
Ronald Buczek, DO
Facility Name
Orthopedic Associates of Southwest Ohio
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Peterson
Phone
937-439-6483
First Name & Middle Initial & Last Name & Degree
Ronald Buczek, DO

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25289343
Citation
Al Youha S, Lalonde DH. Update/Review: changing of use of local anesthesia in the hand. Plast Reconstr Surg Glob Open. 2014 Jun 6;2(5):e150. doi: 10.1097/GOX.0000000000000095. eCollection 2014 May.
Results Reference
background
PubMed Identifier
24644417
Citation
Okamura A, Meirelles LM, Fernandes CH, Raduan Neto J, Dos Santos JB, Faloppa F. Evaluation of patients with carpal tunnel syndrome treated by endoscopic technique. Acta Ortop Bras. 2014;22(1):29-33. doi: 10.1590/S1413-78522014000100005.
Results Reference
background
PubMed Identifier
28890331
Citation
Alter TH, Ilyas AM. A Prospective Randomized Study Analyzing Preoperative Opioid Counseling in Pain Management After Carpal Tunnel Release Surgery. J Hand Surg Am. 2017 Oct;42(10):810-815. doi: 10.1016/j.jhsa.2017.07.003. Epub 2017 Sep 8.
Results Reference
result
PubMed Identifier
18467932
Citation
Boonstra AM, Schiphorst Preuper HR, Reneman MF, Posthumus JB, Stewart RE. Reliability and validity of the visual analogue scale for disability in patients with chronic musculoskeletal pain. Int J Rehabil Res. 2008 Jun;31(2):165-9. doi: 10.1097/MRR.0b013e3282fc0f93.
Results Reference
result
PubMed Identifier
26043053
Citation
Ketonis C, Ilyas AM, Liss F. Pain management strategies in hand surgery. Orthop Clin North Am. 2015 Jul;46(3):399-408, xi. doi: 10.1016/j.ocl.2015.02.008. Epub 2015 Mar 31.
Results Reference
result
PubMed Identifier
27390559
Citation
Ketonis C, Kim N, Liss F, Zmistowski B, Matzon J, Leinberry C, Wang M, Jones C, Abboudi J, Kirkpatrick W, Ilyas AM. Wide Awake Trigger Finger Release Surgery: Prospective Comparison of Lidocaine, Marcaine, and Exparel. Hand (N Y). 2016 Jun;11(2):177-83. doi: 10.1177/1558944715627618. Epub 2016 Mar 8.
Results Reference
result
PubMed Identifier
11018337
Citation
Svensson I, Sjostrom B, Haljamae H. Assessment of pain experiences after elective surgery. J Pain Symptom Manage. 2000 Sep;20(3):193-201. doi: 10.1016/s0885-3924(00)00174-3.
Results Reference
result

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Exparel and Education to Avoid Opioids After Carpal Tunnel Release

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