Exparel and Education to Avoid Opioids After Carpal Tunnel Release

NCT ID: NCT03867539

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2025-03-31

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Differing pain management strategy

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Differing pain management strategy

Intervention Type: OTHER

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.

Interventions

Differing pain management strategy

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Surgery of the Hand

OTHER

Sponsor Role: collaborator

Kettering Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Buczek, DO

Role: PRINCIPAL_INVESTIGATOR

Kettering Health Network

Locations

Orthopedic Associates of Southwest Ohio

Dayton, Ohio, United States

Site Status: RECRUITING

Orthopedic Associates of Southwest Ohio

Dayton, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ronald Buczek, DO

Role: CONTACT

orthostudy2019@gmail.com

937-439-6483

Facility Contacts

Laura Peterson

Role: primary

lpeterson@oaswo.com

937-439-6483

Laura Peterson

Role: primary

937-439-6483

References

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.

Reference Type: BACKGROUND

PMID: 25289343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24644417 (View on PubMed)

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.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 18467932 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26043053 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27390559 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11018337 (View on PubMed)

Other Identifiers

6012435

Identifier Type: -

Identifier Source: org_study_id