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Arthroplasty ComplicationsPhase 4NCT04539730

Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

A Phase 4 study testing Liposomal bupivacaine and Drug: SoC Ropivacaine in people with Arthroplasty Complications and Adductor Canal Block, run by University of Miami.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Liposomal bupivacaine and Drug: SoC Ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 1 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

About this study

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

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.

Being tested
Liposomal bupivacaine, Drug: SoC Ropivacaine
Keywords
Total knee arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal bupivacaineDrug

    Also called Exparel

    266 mg or 20 ml Liposomal Bupivacaine injectable solution

  • Drug: SoC RopivacaineProcedure or surgery

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

Study groups in NCT04539730
Study groupRoleWhat they receive
Ropivacaine Standard of Care GroupActive comparatorParticipants 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.
Receives: Procedure: Drug: SoC Ropivacaine
Liposomal Bupivacaine Intervention GroupExperimentalParticipants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery.
Receives: Drug: Liposomal bupivacaine; Procedure: Drug: SoC Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Use

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

    Measured: Up to 2 weeks

Secondary outcomes (7)

  1. Distance Ambulated with physical therapist

    Average daily distance ambulated using the 6 minute walk test

    Measured: Up to 5 days

  2. Length of hospitalization

    Number of days of hospitalization after elective admission for TKA surgery

    Measured: Up to 5 days

  3. Incidence of events of PONV

    Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization

    Measured: Up to 5 days

  4. Number of participants requiring narcotic prescriptions

    The number of participants that require further narcotic prescriptions will be reported

    Measured: 2 weeks

  5. Incidence of urinary retention from narcotic use

    Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization.

    Measured: 2 Weeks

  6. 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.

    Measured: Up to 5 days

  7. 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

    Measured: Up to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2020
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion1 Dec 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Why it stopped: Did not acquire funding to pursue study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04539730
Sponsor's protocol ID
20200003
Status last verified
Dec 2021
First submitted
31 Aug 2020
Last updated
22 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25376972

  • 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.

    PubMed 29204497

  • 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.

    PubMed 28029532

  • 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.

    PubMed 26117072

  • 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.

    PubMed 27113945

  • 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.

    PubMed 24793570

  • 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.

    PubMed 22546131

  • 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.

    PubMed 25282071

  • 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.

    PubMed 30653126

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal bupivacaine and Drug: SoC Ropivacaine in people with Arthroplasty Complications and Adductor Canal Block, run by University of Miami.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Use (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04539730, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.

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