Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Good Samaritan Regional Medical Center, Oregon

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain Control; Total Knee Arthroplasty

Treatments: Procedure: Adductor canal block; Procedure: Liposomal Bupivacaine Peri-articular Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04086186

IRB16-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Adductor Canal Block Group

Active Comparator group

Description:

Standard method for peri-operative pain control. Adductor canal block is performed by anesthesiologist prior to surgery.

Treatment:

Procedure: Adductor canal block

Liposomal Bupivacaine Group

Experimental group

Description:

Experimental method for peri-operative pain control. Liposomal bupivacaine peri-articular injection is performed by surgeon during surgery.

Treatment:

Procedure: Liposomal Bupivacaine Peri-articular Injection