NCT02274870

Brief Summary

Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Nov 2014

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 14, 2018

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

October 22, 2014

Results QC Date

February 22, 2018

Last Update Submit

June 12, 2018

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity at Movement

    Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.

    24hrs

Secondary Outcomes (9)

  • Pain Intensity at Rest

    24hrs

  • Opioid Consumption

    24hrs

  • Mean Plasma Bupivicaine Level

    72hrs

  • Mean Plasma Bupivacaine Levels

    48hrs

  • Mean Plasma Bupivacaine Level

    24hrs

  • +4 more secondary outcomes

Study Arms (2)

Liposome Bupivacaine,

EXPERIMENTAL

Liposome Bupivacaine 266mg, Knee Infiltration

Drug: Liposome Bupivacaine

Bupivacaine HCl

ACTIVE COMPARATOR

Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs)

Drug: Bupivacaine HCl

Interventions

Liposome BupivacaineDRUG

Administered via local tissue infiltration around the knee joint

Also known as: Bupivacaine Liposome, Injectable Suspension
Liposome Bupivacaine,
Bupivacaine HClDRUG

Administered via CFNB

Also known as: Standard of Care
Bupivacaine HCl

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Status I-III
  • Scheduled to undergo primary unilateral total knee arthroplasty

You may not qualify if:

  • Patients who are pregnant or nursing
  • Alcohol or narcotic dependence within the last 2 years
  • Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
  • BMI \> 40kg/m2
  • Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
  • Allergies to amide-type local anesthetics
  • Any disease condition or lab result that could complicate a patients postoperative recovery
  • History of hypotension
  • Abnormal liver, renal or cardiac function
  • Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franklin

Valley Stream, New York, 11580, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineStandard of Care

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Director of Research, Anesthesiology
Organization
Northwell Health
odowling@northwell.edu
718-470-7630

Study Officials

  • Joseph Marino, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

June 14, 2018

Results First Posted

June 14, 2018

Record last verified: 2018-06

Locations

US(1)