NCT01763814

Brief Summary

Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

December 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

6.2 years

First QC Date

January 2, 2013

Last Update Submit

June 5, 2019

Conditions

Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Change in the Numeric Rating Pain Score

    At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.

    Postoperative

Secondary Outcomes (2)

  • Change in the ability to move the knee

    Postoperative

  • Change in Supplemental pain medications

    Postoperative

Other Outcomes (1)

  • Change in the overall satisfaction

    Postoperative

Study Arms (3)

Single shot femoral nerve block

ACTIVE COMPARATOR

A ultrasound probe will be used to identify the nerve, and correct needle placement.

Procedure: Femoral nerve block

Femoral nerve block non stimulating catheter

ACTIVE COMPARATOR

A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off.

Procedure: Femoral nerve blockProcedure: Femoral nerve block non stimulating catheter

Femoral nerve block stimulating catheter

ACTIVE COMPARATOR

A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on.

Procedure: Femoral nerve blockProcedure: Femoral nerve block stimulating catheter

Interventions

Femoral nerve blockPROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement.

Femoral nerve block non stimulating catheterFemoral nerve block stimulating catheterSingle shot femoral nerve block
Femoral nerve block non stimulating catheterPROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.

Femoral nerve block non stimulating catheter
Femoral nerve block stimulating catheterPROCEDURE

A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.

Femoral nerve block stimulating catheter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Scheduled for total knee arthroplasty

You may not qualify if:

  • Redo surgery on the same knee
  • BMI ≥45
  • Radicular pain in the same leg
  • Allergy to local anesthetics
  • Opioid habituation
  • Pregnancy
  • Contraindication to regional block
  • Inability to communicate with hospital staff or investigators.
  • Neuropathy of any etiology in the surgical extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chicago Anesthesia Pain Specialists

Chicago, Illinois, 60657, United States

Location

Study Officials

  • Antony Tharian, M.D.

    Chicago Anesthesia Pain Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 9, 2013

Study Start

December 1, 2011

Primary Completion

February 1, 2018

Study Completion

April 1, 2019

Last Updated

June 7, 2019

Record last verified: 2019-06

Locations

US(1)