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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01977339
• Other study ID #: 13-0060
• Status: Withdrawn
• Phase: Phase 4
• First received: October 30, 2013
• Last updated: April 19, 2017
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• Liposome Bupivacaine
10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline
• Bupivacaine
20 cc of 0.25% bupivacaine

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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