Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

Adductor Canal Blocks Using Exparel for Pain Control 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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Opioid Use; Arthritis Knee
• Intervention / Treatment: Drug: Exparel; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel; Liposomal Bupivacaine use as active ingredient in the block	Drug: Exparel; Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
Active Comparator: Control; Ropivacaine use as active ingredient in the block	Drug: Ropivacaine; Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Inpatient post-operative stay after undergoing TKA procedure	Through entire inpatient hospital stay (lasted from 1 day to 1 week)
Inpatient Opioid Use	Opioid usage during their inpatient post-operative hospital stay	1 week
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.	6 weeks
Outpatient Opioid Use	Opioid usage in the immediate post-operative period after hospital discharge	6 weeks
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks
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	1 week

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Pennsylvania
• Investigators: Principal Investigator: Chinenye Nwachuku, MD, St. Luke's Hospital and Health Network, Pennsylvania

Publications and helpful links

Helpful Links

• ASA Score Description

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: opioid; knee; arthroplasty; Exparel; adductor
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SLIR 2019-106

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