0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka

NCT03303794 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 2017-7893
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.

Conditions

Anesthesia

Keywords

Total Knee arthroplasty; bupivacaine; anesthesia

Outcome Measures

Primary Outcomes (1)

• AM-PAC Score to Measure Patients Fitness for Discharge

  AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.

  Post-Operation Day 1

Secondary Outcomes (2)

• Opioid Consumption During the First 48 Hours After TKA Surgery

  During the first 48 hours after surgery

• Pain Scores During 48 Hrs Postoperatively

  48 hours postoperatively

Study Arms (2)

Bupivicaine

ACTIVE COMPARATOR

0.25% bupivacaine in patients undergoing total knee arthroplasty

Drug: 0.25% bupivacaine

Bupivicaine + Exparel

EXPERIMENTAL

0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty

Drug: Exparel; Drug: 0.25% bupivacaine

Interventions

Exparel DRUG

1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty

Bupivicaine + Exparel

0.25% bupivacaine DRUG

0.25% bupivacaine in patients undergoing total knee arthroplasty

Also known as: liposomal

Bupivicaine; Bupivicaine + Exparel

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis
• Ages 40- 80 years old
• American Society of Anesthesiologists class I-III

You may not qualify if:

• Refusal or absolute medical contraindication to peripheral nerve block
• refusal or absolute medical contraindication to spinal anesthesia
• conversion of spinal anesthesia to general anesthesia is obtained
• inability to cooperate
• allergy to any drug used in this study
• daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)
• alcohol dependence or use of any illegal drugs within the last month
• inability to perform the mobilization test and timed up and go (TUG) test pre-operatively

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Hutchinson Campus

The Bronx, New York, 10461, United States

Location

Related Publications (37)

• Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24.

  PMID: 23440367 BACKGROUND

• Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.

  PMID: 19258965 BACKGROUND

• Hebl JR, Kopp SL, Ali MH, Horlocker TT, Dilger JA, Lennon RL, Williams BA, Hanssen AD, Pagnano MW. A comprehensive anesthesia protocol that emphasizes peripheral nerve blockade for total knee and total hip arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:63-70. doi: 10.2106/JBJS.E.00491. No abstract available.

  PMID: 16326725 BACKGROUND

• Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.

  PMID: 18362603 BACKGROUND

• Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.

  PMID: 19553071 BACKGROUND

• Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.

  PMID: 18719448 BACKGROUND

• Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.

  PMID: 20889937 BACKGROUND

• Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.

  PMID: 19046884 BACKGROUND

• Klein SM, Nielsen KC, Greengrass RA, Warner DS, Martin A, Steele SM. Ambulatory discharge after long-acting peripheral nerve blockade: 2382 blocks with ropivacaine. Anesth Analg. 2002 Jan;94(1):65-70, table of contents. doi: 10.1097/00000539-200201000-00012.

  PMID: 11772802 BACKGROUND

• Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.

  PMID: 17196495 BACKGROUND

• Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.

  PMID: 19680735 BACKGROUND

• Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. doi: 10.1213/01.ane.0000256006.46703.7f. No abstract available.

  PMID: 17377133 BACKGROUND

• Church S, Robinson TN, Angles EM, Tran ZV, Wallace JI. Postoperative falls in the acute hospital setting: characteristics, risk factors, and outcomes in males. Am J Surg. 2011 Feb;201(2):197-202. doi: 10.1016/j.amjsurg.2009.12.013. Epub 2010 Sep 18.

  PMID: 20851375 BACKGROUND

• Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.

  PMID: 21039357 BACKGROUND

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

  PMID: 24401769 BACKGROUND

• Kennedy JC, Alexander IJ, Hayes KC. Nerve supply of the human knee and its functional importance. Am J Sports Med. 1982 Nov-Dec;10(6):329-35. doi: 10.1177/036354658201000601.

  PMID: 6897495 BACKGROUND

• Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):363-8. doi: 10.1097/AAP.0000000000000269.

  PMID: 26066383 BACKGROUND

• Krenzel BA, Cook C, Martin GN, Vail TP, Attarian DE, Bolognesi MP. Posterior capsular injections of ropivacaine during total knee arthroplasty: a randomized, double-blind, placebo-controlled study. J Arthroplasty. 2009 Sep;24(6 Suppl):138-43. doi: 10.1016/j.arth.2009.03.014. Epub 2009 Jun 10.

  PMID: 19520544 BACKGROUND

• C. Vlessides M. New Regional Technique Controls Post-TKA Pain. Anesthesiology News. December 2012.

  BACKGROUND

• Egeler C, Jayakumar A, Ford S. Motor-sparing knee block - description of a new technique. Anaesthesia. 2013 May;68(5):542-3. doi: 10.1111/anae.12233. No abstract available.

  PMID: 23573861 BACKGROUND

• Mantripragada S. A lipid based depot (DepoFoam technology) for sustained release drug delivery. Prog Lipid Res. 2002 Sep;41(5):392-406. doi: 10.1016/s0163-7827(02)00004-8.

  PMID: 12121719 BACKGROUND

• Richard BM, Newton P, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. The Safety of EXPAREL (R) (Bupivacaine Liposome Injectable Suspension) Administered by Peripheral Nerve Block in Rabbits and Dogs. J Drug Deliv. 2012;2012:962101. doi: 10.1155/2012/962101. Epub 2012 Jan 17.

  PMID: 22363842 BACKGROUND

• Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.

  PMID: 21842428 BACKGROUND

• Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.

  PMID: 22546131 BACKGROUND

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

  PMID: 22067185 BACKGROUND

• Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.

  PMID: 22570563 BACKGROUND

• Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.

  PMID: 26204387 BACKGROUND

• Emerson RH Jr, Barrington JW, Olugbode O, Lovald S, Watson H, Ong K. Femoral Nerve Block Versus Long-Acting Wound Infiltration in Total Knee Arthroplasty. Orthopedics. 2016 May 1;39(3):e449-55. doi: 10.3928/01477447-20160315-03. Epub 2016 Mar 29.

  PMID: 27018607 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

• Haley SM, Coster WJ, Andres PL, Ludlow LH, Ni P, Bond TL, Sinclair SJ, Jette AM. Activity outcome measurement for postacute care. Med Care. 2004 Jan;42(1 Suppl):I49-61. doi: 10.1097/01.mlr.0000103520.43902.6c.

  PMID: 14707755 BACKGROUND

• Jette DU, Stilphen M, Ranganathan VK, Passek SD, Frost FS, Jette AM. AM-PAC "6-Clicks" functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014 Sep;94(9):1252-61. doi: 10.2522/ptj.20130359. Epub 2014 Apr 24.

  PMID: 24764073 BACKGROUND

• Menendez ME, Schumacher CS, Ring D, Freiberg AA, Rubash HE, Kwon YM. Does "6-Clicks" Day 1 Postoperative Mobility Score Predict Discharge Disposition After Total Hip and Knee Arthroplasties? J Arthroplasty. 2016 Sep;31(9):1916-20. doi: 10.1016/j.arth.2016.02.017. Epub 2016 Feb 17.

  PMID: 26993155 BACKGROUND

• Bickler P, Brandes J, Lee M, Bozic K, Chesbro B, Claassen J. Bleeding complications from femoral and sciatic nerve catheters in patients receiving low molecular weight heparin. Anesth Analg. 2006 Oct;103(4):1036-7. doi: 10.1213/01.ane.0000237230.40246.44.

  PMID: 17000826 BACKGROUND

• Buckenmaier CC 3rd, Shields CH, Auton AA, Evans SL, Croll SM, Bleckner LL, Brown DS, Stojadinovic A. Continuous peripheral nerve block in combat casualties receiving low-molecular weight heparin. Br J Anaesth. 2006 Dec;97(6):874-7. doi: 10.1093/bja/ael269. Epub 2006 Oct 9.

  PMID: 17032662 BACKGROUND

• Idestrup C, Sawhney M, Nix C, Kiss A. The incidence of hematoma formation in patients with continuous femoral catheters following total knee arthroplasty while receiving rivaroxaban as thromboprophylaxis: an observational study. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):414-7. doi: 10.1097/AAP.0000000000000127.

  PMID: 25102065 BACKGROUND

• Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.

  PMID: 17377115 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Liposomes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Results Point of Contact

• Title: Dr.Singh Nair
• Organization: Montefiore Medical Center

sinair@montefiore.org

7189205932

Study Officials

• Boleslav Kosharskyy, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 6, 2017
• Study Start: October 25, 2017
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)