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

Anesthesia Clinical Trial

Official title:

Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03303794
• Other study ID #: 2017-7893
• Status: Terminated
• Phase: Phase 3
• Start date: October 25, 2017
• Est. completion date: June 27, 2018

Study information

• Verified date: March 2020
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies:

1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and

2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Exparel
1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
• 0.25% bupivacaine
0.25% bupivacaine in patients undergoing total knee arthroplasty

Locations

Country	Name	City	State
United States	Montefiore Hutchinson Campus	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (37)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2006 Oct 9. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Feibel RJ, Dervin GF, Kim PR, Beaulé 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. — View Citation

Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-404. doi: 10.1016/j.pain.2011.07.005. — View Citation

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. Review. — View Citation

Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lund J, Jenstrup MT, Jaeger P, Sørensen 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. — View Citation

Mantripragada S. A lipid based depot (DepoFoam technology) for sustained release drug delivery. Prog Lipid Res. 2002 Sep;41(5):392-406. Review. — View Citation

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. — View Citation

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. — View Citation

Richard BM, Newton P, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. The Safety of EXPAREL ® (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. — View Citation

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. — View Citation

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. — View Citation

Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. Review. — View Citation

* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid Consumption During the First 48 Hours After TKA Surgery	Monitor how much opioid patient consumes	During the first 48 hours after surgery
Secondary	Pain Scores During 48 Hrs Postoperatively	Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.	48 hours postoperatively