Exparel vs Exparel Plus ACB in TKAs

Sponsor

The Hawkins Foundation (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02365727

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Liposomal bupivacaine Drug: Ropivacaine Drug: Epinephrine Drug: Clonidine Drug: Saline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exparel plus Adductor Canal Block Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine	Drug: Liposomal bupivacaine Other Names: Exparel Drug: Ropivacaine Drug: Epinephrine Drug: Clonidine
Placebo Comparator: Exparel plus Placebo Block Adductor canal block with 20 cc saline	Drug: Liposomal bupivacaine Other Names: Exparel Drug: Saline

Arm

Intervention/Treatment

Experimental: Exparel plus Adductor Canal Block

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

Drug: Liposomal bupivacaine

Other Names:

Exparel

Drug: Ropivacaine

Drug: Epinephrine

Drug: Clonidine

Placebo Comparator: Exparel plus Placebo Block

Adductor canal block with 20 cc saline

Drug: Liposomal bupivacaine

Other Names:

Exparel

Drug: Saline

Outcome Measures

Primary Outcome Measures

Pain as assessed by Visual Analog Scale (VAS) [12 Months]
Pain, as assessed by Visual Analog Scale (VAS)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).