Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

NCT02349542 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 11-14-10B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the use of a standardized periarticular injection containing free bupivacaine and liposomal bupivacaine.

Conditions

Arthroplasty, Replacement, Knee; Pain

Keywords

Liposomal Bupivacaine; Simultaneous Bilateral Total Knee Arthroplasty; Safety

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of Participants with Adverse Events

  Up to 72 hours following injection

Secondary Outcomes (1)

• Plasma Bupivacaine Levels

  Up to 72 hours following injection

Study Arms (1)

Liposomal bupivacaine

EXPERIMENTAL

Patients will receive liposomal bupivacaine following simultaneous bilateral total knee arthroplasty.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.

Also known as: Exparel

Liposomal bupivacaine

Eligibility Criteria

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

You may qualify if:

• Patients deemed appropriate candidates for simultaneous bilateral total knee arthroplasty.
• Patients receiving general anesthesia
• Understands the local language and is willing and able to follow the requirements of the protocol
• Understands the informed consent and signs the institutional review board/ independent ethics committee (IRB/IEC) approved informed consent form

You may not qualify if:

• Patients less than 18 years of age
• Allergy to bupivacaine
• Allergy to epinephrine
• Patients who are not medically cleared to undergo bilateral total knee replacement surgery, or
• Patient-reported liver impairment (per investigator discretion)
• Patient-reported renal impairment (per investigator discretion)
• Patients receiving spinal anesthesia
• Females who are pregnant or lactating

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina, PA

Charlotte, North Carolina, 28209, United States

Location

Related Publications (14)

• Bosco JA 3rd, Slover JD, Haas JP. Perioperative strategies for decreasing infection: a comprehensive evidence-based approach. J Bone Joint Surg Am. 2010 Jan;92(1):232-9. No abstract available.

  PMID: 20048118 BACKGROUND

• Zeni JA Jr, Snyder-Mackler L. Clinical outcomes after simultaneous bilateral total knee arthroplasty: comparison to unilateral total knee arthroplasty and healthy controls. J Arthroplasty. 2010 Jun;25(4):541-6. doi: 10.1016/j.arth.2009.02.016. Epub 2009 Apr 7.

  PMID: 19356894 BACKGROUND

• Taylor BC, Dimitris C, Mowbray JG, Gaines ST, Steensen RN. Perioperative safety of two-team simultaneous bilateral total knee arthroplasty in the obese patient. J Orthop Surg Res. 2010 Jun 17;5:38. doi: 10.1186/1749-799X-5-38.

  PMID: 20565781 BACKGROUND

• Shin YH, Kim MH, Ko JS, Park JA. The safety of simultaneous bilateral versus unilateral total knee arthroplasty: the experience in a Korean hospital. Singapore Med J. 2010 Jan;51(1):44-9.

  PMID: 20200775 BACKGROUND

• Kim SY, An YJ, Kim SH, Kim HK, Park JS, Shin YS. The effect of postoperative pain on postoperative blood loss after sequential bilateral total knee arthroplasty. Korean J Anesthesiol. 2011 Feb;60(2):98-102. doi: 10.4097/kjae.2011.60.2.98. Epub 2011 Feb 25.

  PMID: 21390164 BACKGROUND

• Parvizi J, Miller AG, Gandhi K. Multimodal pain management after total joint arthroplasty. J Bone Joint Surg Am. 2011 Jun 1;93(11):1075-84. doi: 10.2106/JBJS.J.01095.

  PMID: 21655901 BACKGROUND

• Goyal N, McKenzie J, Sharkey PF, Parvizi J, Hozack WJ, Austin MS. The 2012 Chitranjan Ranawat award: intraarticular analgesia after TKA reduces pain: a randomized, double-blinded, placebo-controlled, prospective study. Clin Orthop Relat Res. 2013 Jan;471(1):64-75. doi: 10.1007/s11999-012-2596-9.

  PMID: 23011843 BACKGROUND

• Hutchinson RW, Chon EH, Gilder R, Moss J, Daniel P. A comparison of a fentanyl, morphine, and hydromorphone patient-controlled intravenous delivery for acute postoperative analgesia: a multicenter study of opioid-induced adverse reactions. Hospital Pharmacy 41(7): 659-663, 2006.

  BACKGROUND

• Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001 Nov;13(7):524-39. doi: 10.1016/s0952-8180(01)00320-8.

  PMID: 11704453 BACKGROUND

• Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.

  PMID: 16651569 BACKGROUND

• Horlocker TT, Hebl JR, Kinney MA, Cabanela ME. Opioid-free analgesia following total knee arthroplasty--a multimodal approach using continuous lumbar plexus (psoas compartment) block, acetaminophen, and ketorolac. Reg Anesth Pain Med. 2002 Jan-Feb;27(1):105-8. doi: 10.1053/rapm.2002.27177.

  PMID: 11799514 BACKGROUND

• Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.

  PMID: 15534532 BACKGROUND

• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

  PMID: 22285545 BACKGROUND

• Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet Surg J. 2012 Feb;32(2):186-93. doi: 10.1177/1090820X11434524. Epub 2012 Jan 11.

  PMID: 22238339 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Research Scientist
• Organization: OrthoCarolina Research Institute

susan.odum@orthocarolina.com

704-323-2260

Study Officials

• Susan M Odum, PhD

  Senior Research Scientist

  STUDY DIRECTOR

• Bryan D Springer, MD

  Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 21, 2016
• Last Updated: August 31, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-08

Locations

US (1)