Good Samaritan Regional Medical Center
Corvallis, Oregon, 97330, United States
NCT Number: NCT04086186
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Corvallis, Oregon, 97330, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Exparel peri-articular injection
Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl
Time frame: VAS pain score on post-operative day #1
Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
Time frame: VAS pain score on post-operative day #2
Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
Time frame: VAS pain score on post-operative day #4
Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
Time frame: VAS pain score on post-operative day #7
Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)
Time frame: Outcome measure will be assessed up to 8 weeks
Reported WOMAC Score ranges between 0 (worst) to 100 (best)
Time frame: Outcome measure will be assessed up to 8 weeks
Knee flexion and extension will be recorded during follow up visits
Time frame: Recorded on post-operative day #1
Distance walked in feet will be assessed and recorded by physical therapist
Time frame: Measure outcome will be assess through study completion, on average of 1 year
Measured by number of nights patient stayed in hospital after surgery
Good Samaritan Regional Medical Center, Oregon
Other
Clinical Outcomes of an Adductor Canal Block Versus Liposomal Bupivacaine in Total Knee Arthroplasty Patients: A Randomized Prospective Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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