Intraoperative Liposomal Bupivacaine Injection in Primary Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Prospective Randomized Trial Comparing Intraoperative Liposomal Bupivacaine Injection With Indwelling Femoral Nerve Blockade in Early Postoperative Pain Control for Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02341079
• Other study ID #: NMCSD.2014.0101
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: January 14, 2015
• Last updated: March 7, 2017
• Start date: March 2015
• Est. completion date: October 2015

Study information

• Verified date: March 2017
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Degenerative
• Joint Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthrosis
• Osteoarthrosis Deformans

Intervention

Drug:
• Bupivacaine Liposome Injection
Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.
• Indwelling femoral nerve block
Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale	10cm VAS scale completed by the patient at set intervals postoperatively	0-3 months
Primary	Oral and Intravenous Opioid Consumption	Oral and intravenous opioid use calculated in terms of morphine equivalents	0-5 days (during hospitalization)
Primary	Hospital for Special Surgery (HSS) Knee Scores	Standardized functional clinical score for knee symptoms	0-3 months
Secondary	Length of Hospital Stay		0-5 days
Secondary	Distance ambulated with physical therapy		0-5 days (during hospitalization)
Secondary	Time to straight leg raise with physical therapy	Time to return of quadriceps function	0-5 days (during hospitalization)
Secondary	Postoperative range of motion	Knee range of motion measure by physical therapy and in clinic	0-3 months
Secondary	Postoperative complication rate	All intervention related complications for each arm of the study	0-3 months
Secondary	Plasma bupivacaine concentrations	Plasma levels of bupivacaine monitored throughout hospital stay	0-5 days (during hospitalization)