Exparel Use in Adductor Canal Block After Total Knee Arthroplasty

NCT04910165 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: SLIR 2019-106
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis Knee; Pain, Postoperative; Opioid Use

Keywords

Exparel; adductor; knee; arthroplasty; opioid

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

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

  6 weeks

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

  1 week

Study Arms (2)

Exparel

EXPERIMENTAL

Liposomal Bupivacaine use as active ingredient in the block

Drug: Exparel

Control

ACTIVE COMPARATOR

Ropivacaine use as active ingredient in the block

Drug: Ropivacaine

Interventions

Exparel DRUG

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

Exparel

Ropivacaine DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Block efficacy is dependent on the performing anesthesiologist, with multiple performing anesthesiologists introducing variability that was not accounted for. The use of drains was surgeon specific rather than part of our study protocol. The state's online drug monitoring program reports narcotic prescriptions filled but not necessarily taken possibly pointing to a discrepancy. Finally, all patients were obtained from one demographic area, and all surgeries were only performed by two surgeons

Results Point of Contact

• Title: Dr. Chinenye Nwachuku
• Organization: Saint Luke's University Health Network

chinenye.nwachuku@sluhn.org

6096101054

Study Officials

• Chinenye Nwachuku, MD

  St. Luke's Hospital and Health Network, Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 2, 2021
• Study Start: June 1, 2020
• Primary Completion: September 15, 2021
• Study Completion: October 15, 2021
• Last Updated: May 20, 2022
• Results First Posted: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)