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

NCT01977339 | Withdrawn Phase 4

• 1 other identifier: 13-0060
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

Femoral Nerve Block; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative VAS scores

  1 hr, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs

Other Outcomes (2)

• Sensory mapping (temperature)

  72 hours

• Motor function assessment

  72 hours

Study Arms (2)

Liposome Bupivacaine

EXPERIMENTAL

Single injection femoral nerve block of 10 cc of 266 mg liposome bupivacaine with 10 cc of normal saline

Drug: Liposome Bupivacaine

Bupivacaine

ACTIVE COMPARATOR

Single shot femoral nerve block with 20cc of 0.25% bupivacaine

Drug: Bupivacaine

Interventions

Liposome Bupivacaine DRUG

10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline

Also known as: Exparel

Liposome Bupivacaine

Bupivacaine DRUG

20 cc of 0.25% bupivacaine

Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ali Shariat, MD

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: May 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)