Clinical trial NCT03541265: Liposomal Bupivacaine in Total Knee Arthroplasty
Official title: Efficacy of Regional Adductor Canal Block Using Extended Release Liposomal Bupivacaine in Total Knee Arthroplasty: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Anesthesia, Local
Keywords: liposomal bupivacaine
total knee arthroplasty
Lead sponsor: Bronx-Lebanon Hospital Center Health Care System
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a a randomized prospective study. Patients were assigned into two cohorts on the day of surgery using a randomization software by an independent observer. Randomization was based on age, gender, BMI and type of surgery. The investigators hypothesized that there would be no difference in the pain scores or morphine consumption. Sample size analysis for a randomized prospective trial was performed to achieve an 80% power to detect 20% difference in pain scores (2-point score difference on VAS 0-10 was deemed clinically relevant). A sealed envelope was given to the anesthesiologist and the surgeon on the day of surgery, stating the group that the patient was assigned to participate. All descriptive statistics (Mean, SD) and analysis were performed with SPSS version 21 (IBM) at a 0.05 level of significance.
Primary purpose: TREATMENT

Brief summary: Pain management after total knee arthroplasty is essential for optimized clinical outcomes and higher satisfaction. Exparel (Pacira Pharmaceuticals, Parsippany, New Jersey, USA) is a long-acting Bupivacaine extended release liposome compound that is injected peri-articularly or as regional block. The purpose of this study was to compare the analgesic efficacy of single administration of Exparel for local peri-articular infiltration versus adductor canal regional block.

Detailed description: Multimodal pain approach is now an accepted standard of care to improve pain, enable earlier mobilization and faster recovery, decreased length of stay, and reduce opioid consumption and related side effects. The multimodal approach includes peri-operative oral and IV analgesics, local periarticular injections (PAI), and/or regional blocks such as femoral nerve blocks nerve or subsartorial saphenous nerve (adductor canal) blocks. Extended release bupivacaine (Exparel - Pacira Pharmaceuticals, Parsippany, NJ, USA) in liposomal form was developed for longer lasting post-operative analgesia. There are limited studies analyzing its efficacy of single injection liposomal bupivacaine in adductor canal block in total knee arthroplasty. The investigators hypothesized that a single adductor canal regional block injection would provide similar pain relief as peri-articular infiltration of Exparel.

Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis undergoing unilateral knee replacement

Exclusion Criteria:

* hypersensitivity and/or allergies to local anesthetics or previous knee surgery

Primary outcomes:
measure: Difference in mean pain scores in the first 3 days after surgery
timeFrame: 3 days
Secondary outcomes:
measure: Difference in mean opioid consumption in the first 3 days after surgery
timeFrame: 3 days
Other outcomes:
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