Exparel and Education to Avoid Opioids After Carpal Tunnel Release

NCT03867539 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 6012435
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome

Keywords

hand; exparel; opioid crisis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Failure of alternate pain management strategy

  Within the first few months of study duration

Study Arms (2)

Control Group; Bupivacaine + opioids

ACTIVE COMPARATOR

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.

Drug: Differing pain management strategy

Experimental Group: Exparel, no opioids

EXPERIMENTAL

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.

Drug: Differing pain management strategy

Interventions

Differing pain management strategy DRUG

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.

Control Group; Bupivacaine + opioids; Experimental Group: Exparel, no opioids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• carpal tunnel syndrome diagnosed either by physical exam or EMG
• age \>18.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kettering Health Network: lead
• American Society for Surgery of the Hand: collaborator

Study Sites (2)

Orthopedic Associates of Southwest Ohio

Dayton, Ohio, 45414, United States

RECRUITING

Orthopedic Associates of Southwest Ohio

Dayton, Ohio, 45459, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 25289343 BACKGROUND

• 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.

  PMID: 24644417 BACKGROUND

• 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.

  PMID: 28890331 RESULT

• 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.

  PMID: 18467932 RESULT

• 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.

  PMID: 26043053 RESULT

• 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.

  PMID: 27390559 RESULT

• 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.

  PMID: 11018337 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Ronald Buczek, DO

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Buczek, DO

CONTACT

937-439-6483; orthostudy2019@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: March 8, 2019
• Study Start: February 15, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)