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Completed

NCT Number: NCT04910165

Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

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.

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Key information

Conditions

Arthritis Knee Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exparel

Drug

Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine

Ropivacaine

Drug

Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine

Primary outcomes

  1. Hospital Length of Stay

    Time frame: Through entire inpatient hospital stay (lasted from 1 day to 1 week)

    Inpatient post-operative stay after undergoing TKA procedure

  2. Inpatient Opioid Use

    Time frame: 1 week

    Opioid usage during their inpatient post-operative hospital stay

  3. Numeric Rating Scale (NRS) Pain Score Improvement

    Time frame: 6 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.

  4. Outpatient Opioid Use

    Time frame: 6 weeks

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

  5. WOMAC Score

    Time frame: 6 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 outcomes

  1. Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively

    Time frame: 6 weeks

    Rate of needing to be readmitted to the hospital secondary to inadequate pain control post-operatively at any point during the study period.

  2. Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

St. Luke's Hospital, Pennsylvania

Other

Registry information

Official study title

Adductor Canal Blocks Using Exparel for Pain Control After Total Knee Arthroplasty

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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