Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
Conditions
Keywords
TKA, Knee replacement, Arthritis, Knee
Brief summary
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.
Detailed description
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee arthroplasty procedure will be consented and those meeting study criteria will be randomized to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a multi-drug cocktail, or a multi-drug cocktail alone. This study will recruit subjects on an ongoing basis with a minimum of 130 study participants and a maximum of 156. Efficacy data on surgical pain control and safety data will be collected at frequent intervals during the hospitalization. Each study participant will be followed for a minimum 6 week follow-up period.
Interventions
Sponsors
Holy Cross Hospital, Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 88 years of age. 2. Subject is scheduled to undergo primary unilateral Total Knee Arthroplasty. 3. Subject willing and able to sign the informed consent. 4. Subject is fluent in verbal and written English. 5. Subject agrees to take Liposomal bupivacaine or standard of care equivalent.
Exclusion criteria
1. Previous Partial or Total Knee Arthroplasty of the study knee. Previous Non-Implant surgery on the study knee and contralateral knee is permitted. 2. Subject is pregnant or planning to become pregnant while enrolled in the study. 3. Subject has a history of narcotic or alcohol abuse. 4. Subjects with hepatic disease or renal impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 x upper limit of normal or estimated glomerular filtration rate (eGFR) \< 30 ml/min within 30 days of surgery). 5. For any reason, in the opinion of the investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported Visual Analog Scale (VAS) pain intensity score. Post-surgery hours 4-24. | VAS pain intensity scores will be collected starting four hours after end of surgery and every 4 hours thereafter until hour 24. | The area under the curve (AUC) of the VAS scores from 4-24 hours will be compared between the two treatment groups. |
| Patient reported VAS pain intensity score. Post-surgery hours 24-48. | VAS pain intensity scores will be collected starting 24 hours after end of surgery and every 4 hours thereafter until hour 48, or discharge. | The AUC of the VAS scores from 24-48 hours or until discharge will be compared between the two treatment groups. |
| Patient reported VAS pain intensity score. Post-surgery hours 48-72. | VAS pain intensity scores will be collected starting 48 hours after end of surgery and every 4 hours thereafter until hour 72, or discharge. | The AUC of the VAS scores from 48-72 hours or until discharge will be compared between the two treatment groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost:benefit analysis | TKA hospitalization charges, and VAS pain intensity scores pre-operative on day of surgery, 2-week and 6-week followup visits. | Correlation between hospital charges and improvement in VAS pain intensity score from baseline to the 2-week and 6-week follow-up time points. |
Countries
United States
Outcome results
None listed