Exparel vs Exparel Plus ACB in TKAs

NCT ID: NCT02365727

Last Updated: 2016-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Exparel plus Adductor Canal Block

Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine

Group Type EXPERIMENTAL

Liposomal bupivacaine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Clonidine

Intervention Type DRUG

Exparel plus Placebo Block

Adductor canal block with 20 cc saline

Group Type PLACEBO_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Interventions

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Liposomal bupivacaine

Intervention Type DRUG

Ropivacaine

Intervention Type DRUG

Epinephrine

Intervention Type DRUG

Clonidine

Intervention Type DRUG

Saline

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hawkins Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brayton Shirley

Role: PRINCIPAL_INVESTIGATOR

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Locations

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Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00034356

Identifier Type: -

Identifier Source: org_study_id

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