Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

NCT04539730 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20200003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthroplasty Complications; Adductor Canal Block; Peripheral Nerve Block; Opioid Use

Keywords

Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Opioid Use

  Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents

  Up to 2 weeks

Secondary Outcomes (7)

• Distance Ambulated with physical therapist

  Up to 5 days

• Length of hospitalization

  Up to 5 days

• Incidence of events of PONV

  Up to 5 days

• Number of participants requiring narcotic prescriptions

  2 weeks

• Incidence of urinary retention from narcotic use

  2 Weeks

Study Arms (2)

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.

Procedure: Drug: SoC Ropivacaine

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.

Drug: Liposomal bupivacaine; Procedure: Drug: SoC Ropivacaine

Interventions

Liposomal bupivacaine DRUG

266 mg or 20 ml Liposomal Bupivacaine injectable solution

Also known as: Exparel

Liposomal Bupivacaine Intervention Group

Drug: SoC Ropivacaine PROCEDURE

0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.

Liposomal Bupivacaine Intervention Group; Ropivacaine Standard of Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is scheduled for elective unilateral primary TKA
• The subject is ≥ 18 years
• The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)
• The patient consents for an adductor canal block
• Willing and able to sign an informed consent.

You may not qualify if:

• Patients unwilling or unable to consent to participate in the study.
• Prisoners.
• Pregnancy.
• Reported to have mental illness or belonging to a vulnerable population.
• Subject is \< 18 years of age.
• Patients receiving general anesthesia for the total knee arthroplasty.
• Subject has impaired decision-making capacity per discretion of the Investigator.
• Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.
• Significant pre-existing neuropathy on the operative limb.
• Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I \& II, among others).
• Subject has sustained a significant trauma to the operative knee.
• Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
• Known hypersensitivity and/or allergies to local anesthetics.
• Previous surgery on the affected knee excluding arthroscopic or open meniscectomy.
• Patients with impaired renal function such that they cannot receive IV Toradol.

Sponsors & Collaborators

• University of Miami: lead

Related Publications (9)

• 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.

  PMID: 25376972 BACKGROUND

• 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.

  PMID: 29204497 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.

  PMID: 28029532 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.

  PMID: 26117072 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.

  PMID: 27113945 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.

  PMID: 24793570 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.

  PMID: 22546131 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.

  PMID: 25282071 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.

  PMID: 30653126 BACKGROUND

Related Links

• Related Info

Study Officials

• Jaime Carvajal, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and study team members involved in data collection and data processing will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share