A Comparison of US and Evoked Motor Response-guided Placement of Continuous Femoral Nerve Block Following TKA

April 26, 2017 updated by: Sunnybrook Health Sciences Centre

Comparison of Continuous Femoral Nerve Block Using Ultrasound Versus Ultrasound and Nerve Stimulation Using Stimulating Catheter in Patients Undergoing Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

The purpose of this study is to determine which technique for catheter placement in continuous femoral nerve block (FNB) is most successful - guidance with (1) ultrasound or (2) nerve stimulation and ultrasound. Sensory and motor assessment scores will be obtained post-FNB. Patient controlled analgesia and opiate consumption is also recorded along with pain scores for the first 48 hour post-FNB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Continuous femoral nerve block (cFNB) is a widely used regional anesthetic technique for many lower limb operations, such as total knee arthroplasty (TKA), anterior cruciate ligament repair, tibial osteotomy and patellar surgery. It provides superior pain relief, faster ambulation, shorter hospital stays and less risk of side effects in comparison to patient controlled analgesia (PCA), local anesthetic wound infiltration, or single shot femoral nerve block (FNB).

Stimulating catheters were introduced in 1999 to provide an objective end point to guide continuous nerve block catheter position by maintaining the desired evoked muscle response with nerve stimulation (NS). The main advantages of stimulating catheters are faster onset of sensory and motor block and reduction of local anesthetic drugs consumption. In recent years the precise insertion of continuous catheters has improved especially with the introduction of ultrasound (US)-guided imaging to regional anesthesia practice and advances in scanning techniques. That led to a call to reduce cost by switching to non-stimulating catheters. However, most studies comparing both catheters lacked anesthetic technique standardization and adequate sample size.

In this prospective randomized controlled trial, we compared postoperative analgesic efficacy and opioids consumption in patients having cFNB insertion using US alone and that of US combined with NS.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4Y 1H1
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status I to III patients
  • Aged 18-75 scheduled for unilateral TKA

Exclusion Criteria:

  • History of significant psychiatric problems
  • BMI > 40 kg/m^2
  • Prior surgery in the inguinal region
  • Neurological disease with sensory or motor deficit
  • Diabetic neuropathy
  • Contraindication to any study medications
  • Daily opioid consumption >10 mg PO morphine (or equivalent) for 2 weeks prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
Femoral catheters inserted using ultrasound only
Device: Ultrasound
Femoral catheter inserted using ultrasound only
Active Comparator: Ultrasound + Nerve Stimulation
Femoral catheters inserted using ultrasound with nerve stimulation
Device: Ultrasound + Nerve Stimulation
Femoral catheter inserted using ultrasound and nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean numeric pain score (NRS)
Time Frame: 24 hours post-block insertion
Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10
24 hours post-block insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to perform the block
Time Frame: At the time of block procedure
Time required to perform the block procedure
At the time of block procedure
Sensation over the skin of the thigh to determine sensory block using 3 point grading scale
Time Frame: 30 min post-block insertion
Sensory block evaluation examined the sensation over the skin of the thigh
30 min post-block insertion
Quadriceps muscle strength to determine motor block using 3 point grading scale
Time Frame: 30 min post-block insertion
Motor block evaluation examined quadriceps muscle strength by grading the ability or inability to extend the leg of the limb to be operated on against gravity after the hip is passively flexed at 45°
30 min post-block insertion
Total hydromorphone used (oral and intravenous PCA)
Time Frame: 24 hours post-block
Total amount of hydromorphone consumed within 24 hours post-block
24 hours post-block
Total hydromorphone used (oral and intravenous PCA)
Time Frame: 48 hours post-block
Total amount of hydromorphone consumed within 48 hours post-block
48 hours post-block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2012

Primary Completion (Actual)

December 31, 2012

Study Completion (Actual)

March 31, 2013

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 373-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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