Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910165
• Other study ID #: SLIR 2019-106
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: October 15, 2021

Study information

• Verified date: May 2022
• Source: St. Luke's Hospital, Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis Knee
• Opioid Use
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   ASA Score Description