Adductor Canal Block Versus Liposomal Bupivacaine in TKA

Good Samaritan Regional Medical Center, Oregon60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Total Knee Arthroplasty Post-operative Pain Control

Interventions

Liposomal Bupivacaine Peri-articular InjectionPROCEDURE

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.

Adductor canal blockPROCEDURE

Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Good Samaritan Regional Medical Center

Corvallis, Oregon, United States

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

Time frame: VAS pain score on post-operative day #1

Visual Analog Scale (VAS)

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 Scale (VAS)

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 Scale (VAS)

Visual analog pain scale ranges from zero (no pain) to 10 (maximum pain)

Time frame: VAS pain score on post-operative day #7

Secondary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Reported WOMAC Score ranges between 0 (worst) to 100 (best)

Time frame: Outcome measure will be assessed up to 8 weeks

Knee range of motion

Knee flexion and extension will be recorded during follow up visits

Time frame: Outcome measure will be assessed up to 8 weeks

Ambulation distance after surgery

Distance walked in feet will be assessed and recorded by physical therapist

Time frame: Recorded on post-operative day #1

Hospital length of stay

Measured by number of nights patient stayed in hospital after surgery

Data from ClinicalTrials.gov

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