Effective Pain Management During Shoulder Replacement Surgery With EXPAREL

NCT03474510 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 17-025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effectiveness of post-operative pain control of local infiltration (LIA) of EXPAREL administration to ropivacaine administered via continuous interscalene nerve block (CINB) for postoperative pain relief following shoulder replacement. Effectiveness will be measured in opioid consumption and NRS pain intensity scores from 0-4h, 4-8h, 9-12h, 13-16h, 17-20, 21-24h, 48 hours and 72 hours post-op. Patient satisfaction with pain control; patient functional outcome; adverse events related to CINB, EXPAREL administration, and opioid consumption; and pain intensity scores from the time of surgery until post-operative day 10 (+/- 5 days) will also be examined.

Conditions

Pain, Postoperative; Shoulder Osteoarthritis

Keywords

pain control; EXPAREL; shoulder surgery; continuous interscalene nerve block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Opioid consumption in morphine equivalents within the first 24 hours post-operatively.

  post-operative day 1

Study Arms (2)

EXPAREL

EXPERIMENTAL

Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.

Drug: local infiltration of liposomal bupivacaine

interscalene nerve block

ACTIVE COMPARATOR

Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer.

Other: continuous infusion of ropivacaine interscalene nerve block

Interventions

local infiltration of liposomal bupivacaine DRUG

Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.

EXPAREL

continuous infusion of ropivacaine interscalene nerve block OTHER

All patients will receive a single injection of 30mL, 0.5% preservative-free ropivacaine. Those patients randomized to receive CINB will then have an indwelling catheter placed and held in place by Dermabond and Tegaderm. Placement will be confirmed by ultrasound. Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer.

interscalene nerve block

Eligibility Criteria

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

You may qualify if:

• Surgical candidate for primary total shoulder replacement or reverse total shoulder replacement
• Patient must be 18 years or older
• Patient must be willing and able to sign IRB approved informed consent form, and must be able to understand and agree to follow study protocol.

You may not qualify if:

• Severe bronchopulmonary disease
• Oxygen dependent
• Existing nerve injury
• BMI \> 40
• Coagulation disorders
• Allergy to ropivicaine or bupivacaine
• History of drug or alcohol abuse
• Opioid use within 3 days prior to surgery
• ASA physical status \> lll
• Discharge plan to Skilled nursing facility
• Pregnant women
• Non-English speaking patients

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samarian Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (9)

• Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.

  PMID: 19844772 BACKGROUND

• Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.

  PMID: 20565394 BACKGROUND

• Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. Br J Anaesth. 1998 Oct;81(4):603-5. doi: 10.1093/bja/81.4.603.

  PMID: 9924240 BACKGROUND

• Ilfeld BM, Morey TE, Enneking FK. Continuous infraclavicular brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. Anesthesiology. 2002 Jun;96(6):1297-304. doi: 10.1097/00000542-200206000-00006.

  PMID: 12170039 BACKGROUND

• Bjornholdt KT, Jensen JM, Bendtsen TF, Soballe K, Nikolajsen L. Local infiltration analgesia versus continuous interscalene brachial plexus block for shoulder replacement pain: a randomized clinical trial. Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1245-52. doi: 10.1007/s00590-015-1678-2. Epub 2015 Aug 15.

  PMID: 26276164 BACKGROUND

• Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.

  PMID: 27422692 BACKGROUND

• Hannan CV, Albrecht MJ, Petersen SA, Srikumaran U. Liposomal Bupivacaine vs Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):424-430.

  PMID: 28005096 BACKGROUND

• Jefferey D. Angel M, Chris A. Steel JR, Devin Ong, PhD, Heather Watson, PhD, Scott T. Lovald, PhD. Pain Control after Total and Reverse Shoulder Arthroplasty: Interscalene Block vs. Liposomal Bupivacaine. In: AAOS Annual Meeting. 2016

  BACKGROUND

• Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.

  PMID: 22410178 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 22, 2018
• Study Start: March 17, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)