Exparel vs Exparel Plus ACB in TKAs
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT02365727
- Lead Sponsor
- The Hawkins Foundation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exparel plus Placebo Block Saline Adductor canal block with 20 cc saline Exparel plus Placebo Block Liposomal bupivacaine Adductor canal block with 20 cc saline Exparel plus Adductor Canal Block Liposomal bupivacaine Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine Exparel plus Adductor Canal Block Ropivacaine Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine Exparel plus Adductor Canal Block Epinephrine Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine Exparel plus Adductor Canal Block Clonidine Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
- Primary Outcome Measures
Name Time Method Pain as assessed by Visual Analog Scale (VAS) 12 Months Pain, as assessed by Visual Analog Scale (VAS)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
🇺🇸Greenville, South Carolina, United States