MedPath

Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

Phase 3
Completed
Conditions
Arthritis Knee
Opioid Use
Pain, Postoperative
Interventions
Registration Number
NCT04910165
Lead Sponsor
St. Luke's Hospital, Pennsylvania
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ExparelExparelLiposomal Bupivacaine use as active ingredient in the block
ControlRopivacaineRopivacaine use as active ingredient in the block
Primary Outcome Measures
NameTimeMethod
Outpatient Opioid Use6 weeks

Opioid usage in the immediate post-operative period after hospital discharge

Hospital Length of StayThrough entire inpatient hospital stay (lasted from 1 day to 1 week)

Inpatient post-operative stay after undergoing TKA procedure

Inpatient Opioid Use1 week

Opioid usage during their inpatient post-operative hospital stay

Numeric Rating Scale (NRS) Pain Score Improvement6 weeks

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.

WOMAC Score6 weeks

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
NameTimeMethod
Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively6 weeks

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-Operatively1 week

Rate of needing to be discharged to an inpatient rehabilitation facility after TKA procedure secondary to inadequate pain control and functional recovery

Trial Locations

Locations (1)

St. Luke's University Health Network

🇺🇸

Bethlehem, Pennsylvania, United States

St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States

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