Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-04-22 @ 8:57 PM
Study NCT ID:
NCT02624856
Status:
WITHDRAWN
Last Update Posted:
2020-01-23
First Post:
2015-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Bupivacaine Versus Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2015-12-01', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cumulative pain score assessment', 'timeFrame': '24, 48 and 72 hours postoperatively', 'description': 'Assessment of cumulative pain score reflected by area under the curve (AUC) for NRS scores through 12, 24, 36, 48, 60, and 72 hrs.'}, {'measure': 'Mean daily Opioid consumption', 'timeFrame': '24, 48, 72 hours post-operatively, and until discharge (up to 2 weeks)', 'description': 'Mean daily opioid consumption as morphine equivalents using the online calculator http://www.nyc.gov/html/doh/html/mental/MME.html'}, {'measure': 'Mean length of stay in days', 'timeFrame': 'Through study completion (up to 2 weeks)'}, {'measure': 'Time to first use of postsurgical opioid medication', 'timeFrame': 'Up to 24 hours postoperatively'}, {'measure': 'Proportion of patients receiving no post-surgery rescue opioid medication', 'timeFrame': '0, 6, 12, 24 and 72 hours postoperatively'}, {'measure': 'Discharge to home versus rehabilitation services among the comparison cohorts', 'timeFrame': 'Up to hospital discharge (up to 2 weeks)'}, {'measure': 'Total cost comparisons between the two cohorts', 'timeFrame': 'Up to hospital discharge (up to 2 weeks)', 'description': 'Including medications, nursing care costs, operating room costs, rehabilitation costs'}, {'measure': 'Quality of recovery assessment', 'timeFrame': 'Postoperatively at day 0, 1, 2 and prior to discharge (up to 2 weeks)'}, {'measure': 'Functional outcomes', 'timeFrame': 'At 6 weeks, 3 months, 6 months and 1 year postoperatively', 'description': 'Functional outcomes following total knee arthroplasty at 6 weeks, 3 months, 6 months, 1 year using the Knee Society Score.'}, {'measure': 'Functional outcomes', 'timeFrame': 'At 6 weeks, 3 months, 6 months and 1 year postoperatively', 'description': 'Functional outcomes following total knee arthroplasty at 6 weeks, 3 months, 6 months, 1 year using the Lower Extremity Functional Score'}, {'measure': 'Activity levels', 'timeFrame': 'At 6 weeks, 3 months, 6 months and 1 year postoperatively', 'description': 'Activity levels following total knee arthroplasty at 6 weeks, 3 months, 6 months, and 1 year using the University of California Los Angeles scores'}, {'measure': 'Objective quadriceps strength assessment', 'timeFrame': 'At 24 hours postoperatively', 'description': 'Objective quadriceps strength assessment using a Biodex isokinetic dynamometer at 24 hours post-operatively and at the time of discharge'}, {'measure': 'Patient perceived health outcomes', 'timeFrame': '6 weeks, 3 months, 6 months, and up to 1 year', 'description': 'Patient perceived health outcomes at 6 weeks, 3 months, 6 months, and up to 1 year using Short Form-36 scores'}, {'measure': 'Evaluate and observe any adverse reactions and complications', 'timeFrame': 'From time of randomization through study completion (up to 1 year)'}], 'primaryOutcomes': [{'measure': 'Achievement of rehabilitative goals', 'timeFrame': 'Time until discharge (up to 2 weeks)', 'description': 'Assessment of temporal achievement of rehabilitative goals for discharge (independent ambulation to 100 feet, stair climbing, timed-up-and-go, independent toileting, ability to get dressed independently, capacity to get in and out of bed, capability to sit and rise from a chair/toilet, independence in personal care, mobilization with walker/crutches, and NRS\\<5 on activity).'}], 'secondaryOutcomes': [{'measure': 'Mean postoperative pain score assessment (24, 48 and 72 hours post-operatively)', 'timeFrame': 'Throughout admission (up to 2 weeks)', 'description': 'Assessment of mean post-operative pain using a Numeric rating scale (NRS)- both at rest and during active knee flexion to 45 degree at 24, 48 and 72 hours post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['primary total knee arthroplasty', 'liposomal bupivacaine'], 'conditions': ['Osteoarthritis', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '22842653', 'type': 'BACKGROUND', 'citation': 'Liu SS, Buvanendran A, Rathmell JP, Sawhney M, Bae JJ, Moric M, Perros S, Pope AJ, Poultsides L, Della Valle CJ, Shin NS, McCartney CJ, Ma Y, Shah M, Wood MJ, Manion SC, Sculco TP. Predictors for moderate to severe acute postoperative pain after total hip and knee replacement. Int Orthop. 2012 Nov;36(11):2261-7. doi: 10.1007/s00264-012-1623-5. Epub 2012 Jul 29.'}, {'pmid': '22622607', 'type': 'BACKGROUND', 'citation': 'Lewis C, Gunta K, Mitchell K, Bobay K. Effectiveness of multimodal pain management protocol in total knee arthroplasty patients. Orthop Nurs. 2012 May-Jun;31(3):153-9. doi: 10.1097/NOR.0b013e3182558d0b.'}, {'pmid': '24911371', 'type': 'BACKGROUND', 'citation': 'Barrington JW, Dalury DF, Emerson RH Jr, Hawkins RJ, Joshi GP, Stulberg BN. Improving patient outcomes through advanced pain management techniques in total hip and knee arthroplasty. Am J Orthop (Belle Mead NJ). 2013 Oct;42(10 Suppl):S1-S20.'}, {'pmid': '16651569', 'type': 'BACKGROUND', 'citation': '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': '23759708', 'type': 'BACKGROUND', 'citation': 'Perlas A, Kirkham KR, Billing R, Tse C, Brull R, Gandhi R, Chan VW. The impact of analgesic modality on early ambulation following total knee arthroplasty. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):334-9. doi: 10.1097/AAP.0b013e318296b6a0.'}, {'pmid': '9661552', 'type': 'BACKGROUND', 'citation': 'Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. doi: 10.1097/00000539-199807000-00019.'}, {'pmid': '19309064', 'type': 'BACKGROUND', 'citation': 'Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.'}, {'pmid': '11915059', 'type': 'BACKGROUND', 'citation': 'Wang H, Boctor B, Verner J. The effect of single-injection femoral nerve block on rehabilitation and length of hospital stay after total knee replacement. Reg Anesth Pain Med. 2002 Mar-Apr;27(2):139-44. doi: 10.1053/rapm.2002.29253.'}, {'pmid': '20966667', 'type': 'BACKGROUND', 'citation': 'Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.'}, {'pmid': '22535806', 'type': 'BACKGROUND', 'citation': 'Ng FY, Chiu KY, Yan CH, Ng KF. Continuous femoral nerve block versus patient-controlled analgesia following total knee arthroplasty. J Orthop Surg (Hong Kong). 2012 Apr;20(1):23-6. doi: 10.1177/230949901202000105.'}, {'pmid': '19130163', 'type': 'BACKGROUND', 'citation': 'Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.'}, {'pmid': '23241723', 'type': 'BACKGROUND', 'citation': 'Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.'}, {'pmid': '19046884', 'type': 'BACKGROUND', '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.'}, {'pmid': '24401769', 'type': 'BACKGROUND', '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.'}, {'pmid': '22834681', 'type': 'BACKGROUND', 'citation': 'Jaeger P, Grevstad U, Henningsen MH, Gottschau B, Mathiesen O, Dahl JB. Effect of adductor-canal-blockade on established, severe post-operative pain after total knee arthroplasty: a randomised study. Acta Anaesthesiol Scand. 2012 Sep;56(8):1013-9. doi: 10.1111/j.1399-6576.2012.02737.x. Epub 2012 Jul 26.'}, {'pmid': '22886842', 'type': 'BACKGROUND', 'citation': 'Ishiguro S, Yokochi A, Yoshioka K, Asano N, Deguchi A, Iwasaki Y, Sudo A, Maruyama K. Technical communication: anatomy and clinical implications of ultrasound-guided selective femoral nerve block. Anesth Analg. 2012 Dec;115(6):1467-70. doi: 10.1213/ANE.0b013e31826af956. Epub 2012 Aug 10.'}, {'pmid': '24581899', 'type': 'BACKGROUND', 'citation': 'Pelt CE, Anderson AW, Anderson MB, Van Dine C, Peters CL. Postoperative falls after total knee arthroplasty in patients with a femoral nerve catheter: can we reduce the incidence? J Arthroplasty. 2014 Jun;29(6):1154-7. doi: 10.1016/j.arth.2014.01.006. Epub 2014 Jan 16.'}, {'pmid': '23788068', 'type': 'BACKGROUND', 'citation': 'Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80.'}, {'pmid': '4910702', 'type': 'BACKGROUND', 'citation': 'Moore DC, Bridenbaugh LD, Bridenbaugh PO, Tucker GT. Bupivacaine for peripheral nerve block: A comparison with mepivacaine, lidocaine, and tetracaine. Anesthesiology. 1970 May;32(5):460-3. doi: 10.1097/00000542-197005000-00023. No abstract available.'}, {'pmid': '18503623', 'type': 'BACKGROUND', 'citation': 'de Leeuw MA, Dertinger JA, Hulshoff L, Hoeksema M, Perez RS, Zuurmond WW, de Lange JJ. The efficacy of levobupivacaine, ropivacaine, and bupivacaine for combined psoas compartment-sciatic nerve block in patients undergoing total hip arthroplasty. Pain Pract. 2008 Jul-Aug;8(4):241-7. doi: 10.1111/j.1533-2500.2008.00209.x. Epub 2008 May 23.'}, {'pmid': '22012543', 'type': 'BACKGROUND', 'citation': 'Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.'}, {'pmid': '23833851', 'type': 'BACKGROUND', 'citation': 'Naghipour B, Aghamohamadi D, Azarfarin R, Mirinazhad M, Bilehjani E, Abbasali D, Golzari SE. Dexamethasone added to bupivacaine prolongs duration of epidural analgesia. Middle East J Anaesthesiol. 2013 Feb;22(1):53-7.'}, {'pmid': '21681533', 'type': 'BACKGROUND', 'citation': 'Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.'}, {'pmid': '16094063', 'type': 'BACKGROUND', 'citation': 'Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.'}, {'pmid': '24534592', 'type': 'BACKGROUND', 'citation': 'Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.'}, {'pmid': '23123039', 'type': 'BACKGROUND', 'citation': 'Williams D, Petruccelli D, Paul J, Piccirillo L, Winemaker M, de Beer J. Continuous infusion of bupivacaine following total knee arthroplasty: a randomized control trial pilot study. J Arthroplasty. 2013 Mar;28(3):479-84. doi: 10.1016/j.arth.2012.07.016. Epub 2012 Nov 2.'}, {'pmid': '23857316', 'type': 'BACKGROUND', 'citation': 'Beebe MJ, Allen R, Anderson MB, Swenson JD, Peters CL. Continuous femoral nerve block using 0.125% bupivacaine does not prevent early ambulation after total knee arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1394-9. doi: 10.1007/s11999-013-3164-7.'}, {'pmid': '21039357', 'type': 'BACKGROUND', 'citation': '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': '24476569', 'type': 'BACKGROUND', 'citation': 'Yin C, Matchett G. Intercostal administration of liposomal bupivacaine as a prognostic nerve block prior to phenol neurolysis for intractable chest wall pain. J Pain Palliat Care Pharmacother. 2014 Mar;28(1):33-6. doi: 10.3109/15360288.2013.876485. Epub 2014 Jan 29.'}, {'pmid': '24108252', 'type': 'BACKGROUND', 'citation': 'Ilfeld BM, Malhotra N, Furnish TJ, Donohue MC, Madison SJ. Liposomal bupivacaine as a single-injection peripheral nerve block: a dose-response study. Anesth Analg. 2013 Nov;117(5):1248-56. doi: 10.1213/ANE.0b013e31829cc6ae.'}, {'pmid': '24641895', 'type': 'BACKGROUND', 'citation': 'Lonner J. Role of liposomal bupivacaine in pain management after total joint arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):37-41. doi: 10.3113/jsoa.2014.0037.'}, {'pmid': '24653844', 'type': 'BACKGROUND', 'citation': 'Soberon JR, Duncan SF, Sternbergh WC. Treatment of digital ischemia with liposomal bupivacaine. Case Rep Anesthesiol. 2014;2014:853243. doi: 10.1155/2014/853243. Epub 2014 Feb 5.'}, {'pmid': '24793570', 'type': 'BACKGROUND', 'citation': 'Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.'}, {'pmid': '25248686', 'type': 'BACKGROUND', 'citation': 'Domb BG, Gupta A, Hammarstedt JE, Stake CE, Sharp K, Redmond JM. The effect of liposomal bupivacaine injection during total hip arthroplasty: a controlled cohort study. BMC Musculoskelet Disord. 2014 Sep 24;15:310. doi: 10.1186/1471-2474-15-310.'}, {'pmid': '25282071', 'type': 'BACKGROUND', 'citation': 'Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.'}, {'pmid': '22285545', 'type': 'BACKGROUND', 'citation': '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': '24612918', 'type': 'BACKGROUND', 'citation': 'McAlvin JB, Padera RF, Shankarappa SA, Reznor G, Kwon AH, Chiang HH, Yang J, Kohane DS. Multivesicular liposomal bupivacaine at the sciatic nerve. Biomaterials. 2014 May;35(15):4557-64. doi: 10.1016/j.biomaterials.2014.02.015. Epub 2014 Mar 6.'}, {'pmid': '22363842', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and duration of pain relief after total knee arthroplasty provided by a single injection of liposomal bupivacaine (EXPAREL®) versus standard bupivacaine with an adjuvant, dexamethasone when administered as a quadriceps sparing femoral nerve block and periarticular injection. It is hypothesized that liposomal bupivacaine is superior to standard bupivacaine with dexamethasone and will decrease time to discharge readiness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients of American Society of Anesthesiologist (ASA) I-III physical class with a pre-operative diagnosis of primary osteoarthritis scheduled for elective primary total knee arthroplasty.\n* Patients must be living independently at home prior to undergoing primary total knee arthroplasty with intention of discharge directly to home after hospitalization\n\nExclusion Criteria:\n\n* Subjects will not be eligible for this trial if they have a history of allergy to a local anesthetic\n* Known peripheral neuropathy\n* Known connective tissue or immunological disorders\n* Stroke or other known central nervous system disorders\n* Renal dysfunction\n* Hepatic dysfunction\n* Cardiac dysfunction other than hypertension\n* Pregnant subjects\n* Immunosuppression\n* Human immunodeficiency virus (HIV)\n* Alcohol or drug abuse\n* Chronic pain or opioid dependence\n* Coagulopathy or those unable to comply with study requirements.'}, 'identificationModule': {'nctId': 'NCT02624856', 'briefTitle': 'Liposomal Bupivacaine Versus Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Prospective, Randomized, Double-Blinded, Allocation Concealed Study Comparing the Efficacy of Liposomal Bupivacaine Over Standard Bupivacaine Plus Dexamethasone in Quadriceps Sparing Femoral Nerve Block and Wound Infiltration for Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '4059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liposomal bupivacaine', 'description': 'Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection.', 'interventionNames': ['Drug: Liposomal bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard bupivacaine plus dexamethasone', 'description': 'Bupivacaine 0.5% 10 mL plus 2 mg dexamethasone for quadriceps sparing femoral nerve block and bupivacaine 0.25% 20 mL plus 2 mg of dexamethasone for posterior knee compartment periarticular injection.', 'interventionNames': ['Drug: Bupivacaine plus dexamethasone']}], 'interventions': [{'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'description': 'Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection.', 'armGroupLabels': ['Liposomal bupivacaine']}, {'name': 'Bupivacaine plus dexamethasone', 'type': 'DRUG', 'description': 'Bupivacaine HCl 0.5% 10 mL plus dexamethasone 2 mg for quadriceps sparing femoral nerve block and bupivacaine HCl 0.25% plus dexamethasone 2 mg for posterior knee compartment periarticular injection', 'armGroupLabels': ['Standard bupivacaine plus dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}], 'overallOfficials': [{'name': 'Eric Silverman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albany Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Regional Anesthesia and Acute Pain Management', 'investigatorFullName': 'Eric Silverman', 'investigatorAffiliation': 'Albany Medical College'}}}}