Clinical trial NCT04539730: Liposomal Bupivacaine in Adductor Canal Blocks (ACB)
Official title: Does the Addition of Liposomal Bupivacaine to the Adductor Canal Block Impact Narcotic Use After Primary Total Knee Arthroplasty: a Prospective, Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Arthroplasty Complications
Adductor Canal Block
Peripheral Nerve Block
Opioid Use
Keywords: Total knee arthroplasty
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. The subject is scheduled for elective unilateral primary TKA
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:

1. Patients unwilling or unable to consent to participate in the study.
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.

Primary outcomes:
measure: Opioid Use
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Distance Ambulated with physical therapist
timeFrame: Up to 5 days
measure: Length of hospitalization
timeFrame: Up to 5 days
measure: Incidence of events of PONV
timeFrame: Up to 5 days
measure: Number of participants requiring narcotic prescriptions
timeFrame: 2 weeks
measure: Incidence of urinary retention from narcotic use
timeFrame: 2 Weeks
measure: Post-Operative Pain Score
timeFrame: Up to 5 days
measure: Patient Satisfaction as per the Knee Society Score
timeFrame: Up to Week 6
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Jaime Carvajal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
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. doi: 10.1177/000313481207800540.
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.
citation: 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.