Post-operative Pain Control, Total Knee Arthroplasty
Conditions
Brief summary
This is a randomized prospective study of 60 patients undergoing total knee arthroplasty evaluating the clinical outcomes of liposomal bupivacaine periarticular injections (PAI) when compared to single shot adductor canal block using bupivacaine HCl.
Detailed description
Total knee arthroplasty(TKA) is an effective solution for end stage arthritis of the knee; however, post-surgical pain can be difficult to manage and the optimal peri-operative pain management strategy has not been established. This study serves to evaluate the clinical outcomes of liposomal bupivacaine PAI when compared to single shot adductor canal block using bupivacaine HCl in patients undergoing a TKA. The investigators hypothesized that peri-articular injection with liposomal bupivacaine would not be inferior to an adductor canal block using bupivacaine HCl. A total of 60 patients were recruited. Thirty patients were randomized to receive intraoperative liposomal bupivacaine periarticular injection, and another thirty patients randomized to receive a pre-operative adductor canal block using bupivacaine. Both groups otherwise received standard pain management strategies peri-operatively. The primary outcome of interest was post-operative pain, which was measured using the Visual Analog Scale (VAS). Secondary measures included changes in patient function which was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee range of motion, post-operative ambulation distance, and hospital length of stay.
Interventions
PROCEDURELiposomal Bupivacaine Peri-articular Injection
A 20mL solution of 266mg of liposomal bupivacaine (Exparel) was mixed with 40mL of normal saline, which was then infiltrated consistently in the posterior capsule, medial and lateral side of the arthrotomy, patella tendon, quadriceps tendon, quadriceps musculature, and subcutaneous soft tissue.
PROCEDUREAdductor canal block
Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl
Sponsors
Good Samaritan Regional Medical Center, Oregon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients undergoing unilateral primary total knee arthroplasty for end stage osteoarthritis or rheumatoid arthritis. 2. All adults \> 18 years of age.
Exclusion criteria
1. Not cleared by PCP and appropriate specialists to undergo TKA (Check No if patient has been cleared.) 2. Adults undergoing bilateral primary total knee arthroplasties. 3. Women who are pregnant. 4. Women who are breastfeeding. 5. Inability to receive successful spinal anesthesia. 6. Allergy to amide anesthetics. 7. Inability to receive IV tranexamic acid. 8. Patients who are unable to speak English. 9. Patients who are less than 66kg. 10. Patients who are opioid dependent. We define opioid dependency as patients who are on a long-acting narcotic or patients who are taking more than six tablets of hydrocodone 5mg or equivalent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | VAS pain score on post-operative day #1 | Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Outcome measure will be assessed up to 8 weeks | Reported WOMAC Score ranges between 0 (worst) to 100 (best) |
| Knee range of motion | Outcome measure will be assessed up to 8 weeks | Knee flexion and extension will be recorded during follow up visits |
| Ambulation distance after surgery | Recorded on post-operative day #1 | Distance walked in feet will be assessed and recorded by physical therapist |
| Hospital length of stay | Measure outcome will be assess through study completion, on average of 1 year | Measured by number of nights patient stayed in hospital after surgery |
Countries
United States
Outcome results
None listed