Exparel vs Exparel Plus ACB in TKAs

The Hawkins Foundation

Status and phase: Withdrawn; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Epinephrine; Drug: Saline; Drug: Liposomal bupivacaine; Drug: Clonidine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02365727

Pro00034356

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Exparel plus Adductor Canal Block

Experimental group

Description:

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

Treatment:

Drug: Clonidine

Drug: Ropivacaine

Drug: Liposomal bupivacaine

Drug: Epinephrine

Exparel plus Placebo Block

Placebo Comparator group

Description:

Adductor canal block with 20 cc saline

Treatment:

Drug: Saline

Drug: Liposomal bupivacaine