Clinical trial NCT04910165: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis Knee
Pain, Postoperative
Opioid Use
Keywords: Exparel
adductor
knee
arthroplasty
opioid
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Through entire inpatient hospital stay (lasted from 1 day to 1 week)
measure: Inpatient Opioid Use
timeFrame: 1 week
measure: Numeric Rating Scale (NRS) Pain Score Improvement
timeFrame: 6 weeks
measure: Outpatient Opioid Use
timeFrame: 6 weeks
measure: WOMAC Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Participants Needing to be Readmitted to the Hospital Secondary to Inadequate Pain Control Post-operatively
timeFrame: 6 weeks
measure: Number of Participants Needing to be Admitted to an Inpatient Rehabilitation Facility Post-Operatively
timeFrame: 1 week
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
name: Chinenye Nwachuku, MD
role: PRINCIPAL_INVESTIGATOR
References: