Exparel vs Exparel Plus ACB in TKAs

NCT02365727 — Phase 4, Withdrawn, The Hawkins Foundation

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

Registry	NCT02365727
Status	Withdrawn - Protocol not feasible as written
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	The Hawkins Foundation (Other)
Conditions	Knee Osteoarthritis
Interventions	Liposomal bupivacaine, Ropivacaine, Epinephrine, Clonidine, Saline (Drug)
Dates	start 2015-04-01, primary completion 2015-08-01, completion 2015-08-01, first posted 2015-02-19, last updated 2016-01-14
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Exparel plus Adductor Canal Block	Experimental	Drug: Liposomal bupivacaine; Drug: Ropivacaine; Drug: Epinephrine; Drug: Clonidine	Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
Exparel plus Placebo Block	Placebo comparator	Drug: Liposomal bupivacaine; Drug: Saline	Adductor canal block with 20 cc saline

Liposomal bupivacaine (Drug), also known as Exparel
Ropivacaine (Drug)
Epinephrine (Drug)
Clonidine (Drug)
Saline (Drug)

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Sex: All, ages: 18 Years to 80 Years

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).

+Locations (1)

Facility	City	Country	Status
Steadman Hawkins Clinic of the Carolinas - Greenville Health System	Greenville, South Carolina	United States

+Investigators

Brayton Shirley, Principal investigator, Steadman Hawkins Clinic of the Carolinas - Greenville Health System