Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2021-12-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ropivacaine Standard of Care Group
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.
Drug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
Liposomal Bupivacaine Intervention Group
Participants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery.
Liposomal bupivacaine
266 mg or 20 ml Liposomal Bupivacaine injectable solution
Drug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
Interventions
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Liposomal bupivacaine
266 mg or 20 ml Liposomal Bupivacaine injectable solution
Drug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The subject is ≥ 18 years
3. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)
4. The patient consents for an adductor canal block
5. Willing and able to sign an informed consent.
Exclusion Criteria
2. Prisoners.
3. Pregnancy.
4. Reported to have mental illness or belonging to a vulnerable population.
5. Subject is \< 18 years of age.
6. Patients receiving general anesthesia for the total knee arthroplasty.
7. Subject has impaired decision-making capacity per discretion of the Investigator.
8. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.
9. Significant pre-existing neuropathy on the operative limb.
10. Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I \& II, among others).
11. Subject has sustained a significant trauma to the operative knee.
12. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
13. Known hypersensitivity and/or allergies to local anesthetics.
14. Previous surgery on the affected knee excluding arthroscopic or open meniscectomy.
15. Patients with impaired renal function such that they cannot receive IV Toradol.
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Jaime Carvajal Alba
Assistant Professor
Principal Investigators
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Jaime Carvajal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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20200003
Identifier Type: -
Identifier Source: org_study_id