Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty
Phase 4
Completed
- Conditions
- Knee Osteoarthritis
- Interventions
- Registration Number
- NCT02863120
- Lead Sponsor
- Texas Orthopaedics, Sports and Rehabilitation Associates
- Brief Summary
This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Male or non-pregnant female between the ages of 18-65
- Patients willing and able to sign the informed consent
- Patients able to comply with follow-up requirements including self-evaluations
- Patients requiring a primary total knee replacement
- Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis
Exclusion Criteria
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Patients with inflammatory arthritis
- Patients with a body mass index (BMI) > 40
- Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
- Current use of opioid drugs
- Patients with a history of total or unicompartmental reconstruction of the affected joint
- Patients that have had a high tibial osteotomy or femoral osteotomy
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers
- Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
- Patients with knee fusion to the affected joint
- Patients with an active or suspected latent infection in or about the knee joint
- Patients that are prisoners
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liposomal bupivacaine bupivacaine HCl Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants Liposomal bupivacaine Saline Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants Adductor canal and tibial nerve block bupivacaine HCl Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour Liposomal bupivacaine liposomal bupivacaine Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants Adductor canal and tibial nerve block Ropivacaine Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour
- Primary Outcome Measures
Name Time Method Length of stay (LOS, in days) Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days Time to ambulation (in hours) 2-6 hours
- Secondary Outcome Measures
Name Time Method Pain as assessed by visual analog scale (VAS) on postoperative day 3 72 hours Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Pain as assessed by visual analog scale (VAS) on postoperative day 2 48 hours Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Pain as assessed by visual analog scale (VAS) on postoperative day 1 24 hours Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Postoperative complications and adverse events 2 weeks Pain as assessed by visual analog scale (VAS) on postoperative day 4 96 hours Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Pain as assessed by visual analog scale (VAS) on postoperative day 0 6 hours Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Pain as assessed by visual analog scale (VAS) on postoperative day 5 120 hours Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5
Opioid consumption in oral morphine equivalents (OMEs, in milligrams) Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
Trial Locations
- Locations (1)
Texas Orthopedics
🇺🇸Austin, Texas, United States