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0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka

Sponsor
Montefiore Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03303794
Collaborator
(none)
25
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Total knee and hip replacements are some of the most common orthopedic procedures that require aggressive postoperative pain management. This management helps us to improve clinical outcomes such as participation in early physical therapy, hospital discharge, and patient satisfaction. Based on the recent anatomical evidence and the investigator's knowledge of the complexity of the knee joint innervation the investigator proposes a new regional anesthesia technique that provides a complete sensory blockade and better analgesia while preserving the quadriceps strength and avoiding the potential for foot drop caused by inadvertent blockade of the common peroneal nerve.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of this study is the proportion of patients "fit to discharge" on postoperative day one. Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel) uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been used in clinical practice for decades for peripheral nerve block, spinal, and epidural analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine for up to 72 hours with a single injection. The study was designed to compare two of our current standard therapies:

  1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration using 0.25% bupivacaine; and

  2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment + posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5% bupivacaine HCl mixture.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study
Actual Study Start Date :
Oct 25, 2017
Actual Primary Completion Date :
Jun 27, 2018
Actual Study Completion Date :
Jun 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupivicaine

0.25% bupivacaine in patients undergoing total knee arthroplasty

Drug: 0.25% bupivacaine
0.25% bupivacaine in patients undergoing total knee arthroplasty
Other Names:
  • liposomal

    		•
    Experimental: Bupivicaine + Exparel

    0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty

    Drug: Exparel
    1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty

    Drug: 0.25% bupivacaine
    0.25% bupivacaine in patients undergoing total knee arthroplasty
    Other Names:
  • liposomal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. AM-PAC Score to Measure Patients Fitness for Discharge [Post-Operation Day 1]

      AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.

    Secondary Outcome Measures

    1. Opioid Consumption During the First 48 Hours After TKA Surgery [During the first 48 hours after surgery]

      Monitor how much opioid patient consumes

    2. Pain Scores During 48 Hrs Postoperatively [48 hours postoperatively]

      Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients undergoing unilateral total knee replacement due to OA or rheumatoid arthritis

    • Ages 40- 80 years old

    • American Society of Anesthesiologists class I-III

    Exclusion Criteria:

    • Refusal or absolute medical contraindication to peripheral nerve block

    • refusal or absolute medical contraindication to spinal anesthesia

    • conversion of spinal anesthesia to general anesthesia is obtained

    • inability to cooperate

    • allergy to any drug used in this study

    • daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)

    • alcohol dependence or use of any illegal drugs within the last month

    • inability to perform the mobilization test and timed up and go (TUG) test pre-operatively

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Montefiore Hutchinson Campus Bronx New York United States 10461

    Sponsors and Collaborators

    • Montefiore Medical Center

    Investigators

    • Principal Investigator: Boleslav Kosharskyy, MD, Montefiore Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Singh Nair, Investigator, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03303794
    Other Study ID Numbers:
    • 2017-7893
    First Posted:
    Oct 6, 2017
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020
    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.:
    Yes
    Keywords provided by Singh Nair, Investigator, Montefiore Medical Center
    Total Knee arthroplasty
    bupivacaine
    anesthesia
    Additional relevant MeSH terms:
    Bupivacaine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Bupivicaine Bupivicaine + Exparel
    Arm/Group Description 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
    Period Title: Overall Study
    STARTED 13 12
    COMPLETED 13 12
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Bupivicaine Bupivicaine + Exparel Total
    Arm/Group Description 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty Total of all reporting groups
    Overall Participants 13 12 25
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    6
    50%
    6
    24%
    >=65 years
    13
    100%
    6
    50%
    19
    76%
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    71
    67
    70
    Sex: Female, Male (Count of Participants)
    Female
    10
    76.9%
    8
    66.7%
    18
    72%
    Male
    3
    23.1%
    4
    33.3%
    7
    28%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    13
    100%
    12
    100%
    25
    100%

    Outcome Measures

    1. Primary Outcome
    Title AM-PAC Score to Measure Patients Fitness for Discharge
    Description AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.
    Time Frame Post-Operation Day 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bupivicaine Bupivicaine + Exparel
    Arm/Group Description 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
    Measure Participants 13 12
    Mean (Inter-Quartile Range) [score on scale]
    23
    23
    2. Secondary Outcome
    Title Opioid Consumption During the First 48 Hours After TKA Surgery
    Description Monitor how much opioid patient consumes
    Time Frame During the first 48 hours after surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bupivicaine Bupivicaine + Exparel
    Arm/Group Description 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
    Measure Participants 13 12
    Mean (Inter-Quartile Range) [milligram]
    90
    76
    3. Secondary Outcome
    Title Pain Scores During 48 Hrs Postoperatively
    Description Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.
    Time Frame 48 hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Bupivicaine Bupivicaine + Exparel
    Arm/Group Description 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
    Measure Participants 13 12
    Mean (Inter-Quartile Range) [score on scale]
    4
    4

    Adverse Events

    Time Frame Adverse event data were collected up until 48 hours post operation.
    Adverse Event Reporting Description
    Arm/Group Title Bupivicaine Bupivicaine + Exparel
    Arm/Group Description 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty 0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty
    All Cause Mortality
    Bupivicaine Bupivicaine + Exparel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 0/12 (0%)
    Serious Adverse Events
    Bupivicaine Bupivicaine + Exparel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Bupivicaine Bupivicaine + Exparel
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 0/12 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr.Singh Nair
    Organization Montefiore Medical Center
    Phone 7189205932
    Email sinair@montefiore.org
    Responsible Party:
    Singh Nair, Investigator, Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT03303794
    Other Study ID Numbers:
    • 2017-7893
    First Posted:
    Oct 6, 2017
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020