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Did not acquire funding to pursue study
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The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine Standard of Care Group | Active Comparator | Participants undergoing elective Total Knee Arthoplasty (TKA) surgery that are randomized to the control group will undergo an ultrasound-guided Adductor Canal Block (ACB) with standard of care (SoC) Ropivacaine post TKA surgery. |
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| Liposomal Bupivacaine Intervention Group | Experimental | Participants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | 266 mg or 20 ml Liposomal Bupivacaine injectable solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents | Up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Ambulated with physical therapist | Average daily distance ambulated using the 6 minute walk test | Up to 5 days |
| Length of hospitalization | Number of days of hospitalization after elective admission for TKA surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Carvajal, MD | University of Miami | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25376972 | Background | Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169. | |
| 29204497 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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Participants and study team members involved in data collection and data processing will be blinded to the intervention.
| Drug: SoC Ropivacaine | Procedure | 0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine. |
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| Up to 5 days |
| Incidence of events of PONV | Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization | Up to 5 days |
| Number of participants requiring narcotic prescriptions | The number of participants that require further narcotic prescriptions will be reported | 2 weeks |
| Incidence of urinary retention from narcotic use | Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization. | 2 Weeks |
| Post-Operative Pain Score | Post-Operative Pain will be measured via a self-reported Visual Analog Scale (VAS) score. The VAS Pain score ranges from 1-10 with 1 being free of pain and 10 being the most pain. | Up to 5 days |
| Patient Satisfaction as per the Knee Society Score | The Knee society score has a total score ranging from 100-0. Scores between 100 and 85 points are considered excellent results, scores between 84 and 70 points are considered good results. Scores between 69 and 60 points are considered fair, and scores less than 60 are considered poor results | Up to Week 6 |
| Thacher RR, Hickernell TR, Grosso MJ, Shah R, Cooper HJ, Maniker R, Brown AR, Geller J. Decreased risk of knee buckling with adductor canal block versus femoral nerve block in total knee arthroplasty: a retrospective cohort study. Arthroplast Today. 2017 Apr 15;3(4):281-285. doi: 10.1016/j.artd.2017.02.008. eCollection 2017 Dec. |
| 28029532 | Background | Singh PM, Borle A, Trikha A, Michos L, Sinha A, Goudra B. Role of Periarticular Liposomal Bupivacaine Infiltration in Patients Undergoing Total Knee Arthroplasty-A Meta-analysis of Comparative Trials. J Arthroplasty. 2017 Feb;32(2):675-688.e1. doi: 10.1016/j.arth.2016.09.042. Epub 2016 Oct 8. |
| 26117072 | Background | Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3. |
| 27113945 | Background | Jain RK, Porat MD, Klingenstein GG, Reid JJ, Post RE, Schoifet SD. The AAHKS Clinical Research Award: Liposomal Bupivacaine and Periarticular Injection Are Not Superior to Single-Shot Intra-articular Injection for Pain Control in Total Knee Arthroplasty. J Arthroplasty. 2016 Sep;31(9 Suppl):22-5. doi: 10.1016/j.arth.2016.03.036. Epub 2016 Mar 26. |
| 24793570 | Background | 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. |
| 22546131 | 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. |
| 25282071 | Background | 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. |
| 30653126 | Background | Zhao B, Ma X, Zhang J, Ma J, Cao Q. The efficacy of local liposomal bupivacaine infiltration on pain and recovery after Total Joint Arthroplasty: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2019 Jan;98(3):e14092. doi: 10.1097/MD.0000000000014092. |