Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
Primary Purpose
Arthritis Knee, Pain, Postoperative, Opioid Use
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exparel
Ropivacaine
Sponsored by

About this trial
This is an interventional treatment trial for Arthritis Knee focused on measuring Exparel, adductor, knee, arthroplasty, opioid
Eligibility Criteria
Inclusion Criteria:
- Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.
Exclusion Criteria:
- Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
Sites / Locations
- St. Luke's University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exparel
Control
Arm Description
Liposomal Bupivacaine use as active ingredient in the block
Ropivacaine use as active ingredient in the block
Outcomes
Primary Outcome Measures
Hospital Length of Stay
Inpatient post-operative stay after undergoing TKA procedure
Inpatient Opioid Use
Opioid usage during their inpatient post-operative hospital stay
Numeric Rating Scale (NRS) Pain Score Improvement
Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels.
Outpatient Opioid Use
Opioid usage in the immediate post-operative period after hospital discharge
WOMAC Score
Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels.
Secondary Outcome Measures
Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period.
Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery
Full Information
NCT ID
NCT04910165
First Posted
May 25, 2021
Last Updated
May 18, 2022
Sponsor
St. Luke's Hospital, Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04910165
Brief Title
Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
Official Title
Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital, Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks for peri-operative pain control following a total knee arthroplasty (TKA) procedure.
Detailed Description
The effectiveness of an Exparel Block (Bupivacaine Liposomal Injectable Suspension) for post-operative pain control has been well studied with encouraging results. At the investigators' institution, Exparel has been approved as a safe and effective option for use in shoulder surgeries and have had encouraging results in adductor canal use for pain control in patients undergoing TKA. Exparel has been shown to have better pain control compared to previously used infiltration agents, including bupivacaine, while having a minor side effect profile. The purpose of this study is to explore the effectiveness of Exparel (liposomal bupivacaine) in Adductor Canal Blocks (ACB) for peri-operative pain control following a total knee arthroplasty (TKA) procedure. Specifically, the investigators look to see if Exparel ACB reduces opioid requirement use post-operatively, reduces pain scores post-operatively, provides earlier mobilization, and decreases length of hospital stay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee, Pain, Postoperative, Opioid Use
Keywords
Exparel, adductor, knee, arthroplasty, opioid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel
Arm Type
Experimental
Arm Description
Liposomal Bupivacaine use as active ingredient in the block
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Ropivacaine use as active ingredient in the block
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Inpatient post-operative stay after undergoing TKA procedure
Time Frame
Through entire inpatient hospital stay (lasted from 1 day to 1 week)
Title
Inpatient Opioid Use
Description
Opioid usage during their inpatient post-operative hospital stay
Time Frame
1 week
Title
Numeric Rating Scale (NRS) Pain Score Improvement
Description
Measured with Numerical Rating Scale (Range: 0-10, Minimum:0, Maximum:10). Change in NRS Pain Score from pre-operative levels. Positive changes indicate a decrease in pain levels from pre-operative levels.
Time Frame
6 weeks
Title
Outpatient Opioid Use
Description
Opioid usage in the immediate post-operative period after hospital discharge
Time Frame
6 weeks
Title
WOMAC Score
Description
Western Ontario and McMaster Universities Osteoarthritis Index Patient Subjective Outcome Score (Range: 0-96, Minimum:0, Maximum:96). Subsections include Pain (Range:0-20, Minimum:0, Maximum:20), Stiffness (Range:0-8; Minimum:0, Maximum:8), and Functional Limitation (Range0-68, Minimum:0, Maximum:68). Measured as change in score from baseline levels. Positive scores indicate an improvement in WOMAC scores from pre-operative levels.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
Description
Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period.
Time Frame
6 weeks
Title
Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
Description
Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients were eligible for inclusion if they were undergoing unilateral primary TKA for a diagnosis of knee osteoarthritis and were not undergoing any additional concomitant procedures were.
Exclusion Criteria:
Patients were not eligible for our study if they were undergoing revision TKA, if they were undergoing bilateral TKA or concomitant procedures, or if they had an active infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinenye Nwachuku, MD
Organizational Affiliation
St. Luke's Hospital and Health Network, Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exparel Use in Adductor Canal Block After Total Knee Arthroplasty
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