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Completed

NCT Number: NCT01763814

Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Arthroplasty

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chicago Anesthesia Pain Specialists

Chicago, Illinois, 60657, United States

About this study

This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:

Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18- 90 years old
  • Scheduled for total knee arthroplasty

Exclusion criteria

  • 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.

Treatment and study plan

Femoral Nerve Block

Procedure

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

Femoral nerve block non stimulating catheter

Procedure

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 stimulating catheter

Procedure

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

Primary outcomes

  1. Change in the Numeric Rating Pain Score

    Time frame: Postoperative

    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.

Secondary outcomes

  1. Change in the ability to move the knee

    Time frame: Postoperative

    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.

  2. Change in Supplemental pain medications

    Time frame: Postoperative

    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.

Other outcomes

  1. Change in the overall satisfaction

    Time frame: Postoperative

    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.

Sponsors and collaborators

Lead sponsor

Chicago Anesthesia Pain Specialists

Other

Registry information

Official study title

A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Jan 9, 2013
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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