NCT04086186

Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Clinical Outcomes of an Adductor Canal Block Versus Liposomal Bupivacaine in Total Knee Arthroplasty Patients: A Randomized Prospective Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Good Samaritan Regional Medical Center, Oregon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Total Knee Arthroplasty
• Post-operative Pain Control

Interventions

Type	Name	Description
PROCEDURE	Liposomal 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.
PROCEDURE	Adductor canal block	Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl

Timeline

• Start date: 2017-03-22
• Primary completion: 2018-11-25
• Completion: 2018-12-18
• First posted: 2019-09-11
• Last updated: 2019-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study