Exparel vs Exparel Plus ACB in TKAs

Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02365727

Enrollment

Registered

2015-02-19

Start date

2015-04-30

Completion date

2015-08-31

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.

Interventions

DRUGLiposomal bupivacaine

DRUGRopivacaine

DRUGEpinephrine

DRUGClonidine

DRUGSaline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Male or female, aged 18 to 80 years at the time of surgery. * Willing and able to give voluntary informed consent to participate in this investigation. * Candidate for total knee arthroplasty. * BMI \< 35.

Exclusion criteria

* Subject has had previous arthroplasty or fracture procedure(s) on the operative knee. * Creatine level ≥ 1.5 * Pre-existing gait disturbance or neuropathy. * Allergy to local anesthetics. * Inflammatory arthropathies. * Female patient who is pregnant or nursing. * Chronic use of narcotics * Any other reason (in the judgment of the investigator).

Design outcomes

Primary

Measure	Time frame	Description
Pain as assessed by Visual Analog Scale (VAS)	12 Months	Pain, as assessed by Visual Analog Scale (VAS)

Secondary

Measure	Time frame	Description
Function as assessed by Knee Society Score (KSS) and EQ-5D	12 Months	Function, as assessed by Knee Society Score (KSS) and EQ-5D
Opioid consumption as assessed by dosage and frequency of narcotic usage	30 hours	Opioid consumption, as assessed by dosage and frequency of narcotic usage

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026