Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

NCT ID: NCT02341079

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-10-31

Brief Summary

The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.

Detailed Description

Postoperative pain control in total knee arthroplasty is generally managed by a multimodal approach of premedication, epidural and/or peripheral nerve blocks, narcotic medications, and anti-inflammatories. Multiple studies have evaluated the efficacy of anesthetic "cocktails" of various medications for local tissue infiltration to aide in controlling postoperative pain. A recent systematic review supported the use of local anesthetic infiltration in a single intraoperative dose as an adjunct to femoral nerve block in the relief of pain; with combinations of ropivacaine, ketorolac, and adrenaline providing the best results. Several studies noted decreases in opioid consumption and overall pain scores in the perioperative period.

A novel compound, liposomal bupivacaine (EXPAREL®, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA), has been proposed for use in total knee arthroplasty. To our knowledge, only one randomized controlled trial involving use of this compound in total knee arthroplasty has been published and was performed as a phase two dose ranging trial comparing liposomal bupivacaine to bupivacaine HCl. No statistically significant difference between the two compounds was shown, but a trend towards benefit in short term pain control was shown with EXPAREL 532mg.

Our current pain management regimen utilizes the multimodal approach of neuraxial anesthesia, indwelling femoral nerve catheter, opioids, and anti-inflammatory medications. The regional anesthesia service manages postoperative pain while the indwelling femoral nerve catheter is in place. The epidural is utilized for early postoperative analgesia and thromboprophylaxis. The epidural is discontinued on post-operative day 1 and the femoral nerve catheter is removed by the morning of postoperative day 3. Although femoral nerve catheters provide excellent pain control following TKA, there are associated disadvantages. Most notably there is inherent quadriceps weakness which places the patient at increased fall risk. To reduce the risk of falling, patients must wear a knee immobilizer with ambulation until the catheter is removed and quadriceps function has returned. This may delay the ability to actively participate in physical therapy.

The purpose of our present study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain. The investigators aim to show equivalency between the two treatment modalities. Our hypothesis is that a systematic local infiltration of liposomal bupivacaine provided intraoperatively is equally efficacious as femoral indwelling peripheral nerve blockade in immediate postoperative pain control with more rapid progression with physical therapy.

Conditions

Osteoarthritis; Osteoarthritis, Knee; Arthritis, Degenerative; Osteoarthrosis; Osteoarthrosis Deformans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Femoral Nerve Blockade

Femoral nerve block delivered via indwelling femoral nerve catheter

Group Type: ACTIVE_COMPARATOR

Indwelling femoral nerve block

Intervention Type: DRUG

Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.

Bupivacaine Liposome Injection

Intraoperative intracapsular injection of bupivacaine liposome

Group Type: EXPERIMENTAL

Bupivacaine Liposome Injection

Intervention Type: DRUG

Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.

Interventions

Bupivacaine Liposome Injection

Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.

Intervention Type: DRUG

Indwelling femoral nerve block

Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.

Intervention Type: DRUG

Other Intervention Names

EXPAREL

Eligibility Criteria

Inclusion Criteria

• Age over 18 years old
• Undergoing unilateral primary total knee arthroplasty

Exclusion Criteria

• Revision total knee arthroplasty
• Bilateral total knee arthroplasty
• Prior allergy or adverse reaction to local anesthetic
• Hepatic dysfunction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick B Morrissey, M.D.

Role: PRINCIPAL_INVESTIGATOR

Naval Medical Center San Diego Department of Orthopadic Surgery

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2014.0101

Identifier Type: -

Identifier Source: org_study_id