Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

December 6, 2021 updated by: Jaime Carvajal Alba, University of Miami

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
Procedure: Drug: SoC Ropivacaine
0.5% (5mg/mL) 20 mL single dose SOC anesthetic Ropivacaine.
Drug: Liposomal bupivacaine
266 mg or 20 ml Liposomal Bupivacaine injectable solution
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Use
Time Frame: Up to 2 weeks
Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents
Up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance Ambulated with physical therapist
Time Frame: Up to 5 days
Average daily distance ambulated using the 6 minute walk test
Up to 5 days
Length of hospitalization
Time Frame: Up to 5 days
Number of days of hospitalization after elective admission for TKA surgery
Up to 5 days
Incidence of events of PONV
Time Frame: Up to 5 days
Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization
Up to 5 days
Number of participants requiring narcotic prescriptions
Time Frame: 2 weeks
The number of participants that require further narcotic prescriptions will be reported
2 weeks
Incidence of urinary retention from narcotic use
Time Frame: 2 Weeks
Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization.
2 Weeks
Post-Operative Pain Score
Time Frame: 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.
Up to 5 days
Patient Satisfaction as per the Knee Society Score
Time Frame: 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
Up to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20200003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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