Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty

A Randomized, Double-Blinded, Control Trial to Evaluate the Efficacy of Single Injection Femoral Nerve Block With Liposome Bupivacaine for Postsurgical Analgesia in Subjects Undergoing Unilateral Total Knee Arthroplasty

The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: Liposome Bupivacaine; Drug: Bupivacaine

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • St. Luke's-Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, ≥18 years of age
2. Scheduled to undergo primary unilateral TKA under general anesthesia.
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
2. Planned concurrent surgical procedure (e.g., bilateral TKA).
3. Body weight < 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
4. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
5. Previous participation in a liposome bupivacaine study.
6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposome Bupivacaine; Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline	Drug: Liposome Bupivacaine; 10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline; Other Names: Exparel
Active Comparator: Bupivacaine; Single shot femoral nerve block with 20cc of 0.25% bupivacaine	Drug: Bupivacaine; 20 cc of 0.25% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opiate consumption	Compare the cumulative 72 hour opiate consumption after total knee arthroplasty (TKA)in patients who received a single dose of liposome bupivacaine with those who received a single shot femoral nerve block with 0.25% bupivacaine.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative VAS scores	Patients will be asked to describe the pain intensity under two circumstances: pain at rest, and pain on movement. Postoperative pain intensity will be evaluated using the Visual Analogue Scale (VAS) system at 1, 4, 8, 12, 24, 48 and 72 hours. The VAS used will be the 11 point verbal response pain scale with 0 being no pain at all and 10 being the worst possible pain. The patients will be asked to rate their pain levels using this numeric scale.	1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensory mapping (temperature)	Sensation in the distribution of the femoral nerve as assessed by temperature using an alcohol swab (0=no sensation, 1=decreased sensation, 2=normal).	72 hours
Motor function assessment	The ability to walk 20 meters unassisted with the optional use of a 4-legged walker at baseline, and at 24, 48 and 72 hours post-operatively.	72 hours

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Ali Shariat, MD, St. Luke's-Roosevelt Hospital Center

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Femoral Nerve Block; Liposomal Bupivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 13-0060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No