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Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

Sponsor
University of Miami (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04539730
Collaborator
(none)
0
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal bupivacaine
  • Procedure: Drug: SoC Ropivacaine
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants and study team members involved in data collection and data processing will be blinded to the intervention.
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Procedure: Drug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
Experimental: 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.

Drug: Liposomal bupivacaine
266 mg or 20 ml Liposomal Bupivacaine injectable solution
Other Names:
  • Exparel

    • Procedure: Drug: SoC Ropivacaine
    0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.

    Outcome Measures

    Primary Outcome Measures

    1. Opioid Use [Up to 2 weeks]

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

    Secondary Outcome Measures

    1. Distance Ambulated with physical therapist [Up to 5 days]

      Average daily distance ambulated using the 6 minute walk test

    2. Length of hospitalization [Up to 5 days]

      Number of days of hospitalization after elective admission for TKA surgery

    3. Incidence of events of PONV [Up to 5 days]

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

    4. Number of participants requiring narcotic prescriptions [2 weeks]

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

    5. Incidence of urinary retention from narcotic use [2 Weeks]

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

    6. Post-Operative Pain Score [Up to 5 days]

      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.

    7. Patient Satisfaction as per the Knee Society Score [Up to Week 6]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Jaime Carvajal, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Jaime Carvajal Alba, Assistant Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT04539730
    Other Study ID Numbers:
    • 20200003
    First Posted:
    Sep 7, 2020
    Last Update Posted:
    Dec 22, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Jaime Carvajal Alba, Assistant Professor, University of Miami
    Total knee arthroplasty
    Additional relevant MeSH terms:
    Bupivacaine
    Ropivacaine

    Study Results

    No Results Posted as of Dec 22, 2021