Total Knee Arthroplasty
Conditions
Keywords
Femoral Nerve Block, Liposomal Bupivacaine
Brief summary
The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.
Interventions
10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline
DRUGBupivacaine
20 cc of 0.25% bupivacaine
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, ≥18 years of age 2. Scheduled to undergo primary unilateral TKA under general anesthesia. 3. American Society of Anesthesiology (ASA) Physical Status I-III 4. Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold. 5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Exclusion criteria
1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration. 2. Planned concurrent surgical procedure (e.g., bilateral TKA). 3. Body weight \< 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2. 4. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine). 5. Previous participation in a liposome bupivacaine study. 6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opiate consumption | 72 hours | Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative VAS scores | 1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs | Patients will be asked to describe the pain intensity under two circumstances: pain at rest, and pain on movement. Postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) system at 1, 4, 8, 12, 24, 48 and 72 hours. The VAS used will be the 11 point verbal response pain scale with 0 being no pain at all and 10 being the worst possible pain. The patients will be asked to rate their pain levels using this numeric scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensory mapping (temperature) | 72 hours | Sensation in the distribution of the femoral nerve as assessed by temperature using an alcohol swab (0=no sensation, 1=decreased sensation, 2=normal). |
| Motor function assessment | 72 hours | The ability to walk 20 meters unassisted with the optional use of a 4-legged walker at baseline, and at 24, 48 and 72 hours post-operatively. |
Countries
United States
Outcome results
None listed