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Completed

NCT Number: NCT03121976

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4Y 1H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ultrasound

Device

Femoral catheter inserted using ultrasound only

Ultrasound + Nerve Stimulation

Device

Femoral catheter inserted using ultrasound and nerve stimulation

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to perform the block

    Time frame: At the time of block procedure

    Time required to perform the block procedure

  2. 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

  3. 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°

  4. Total hydromorphone used (oral and intravenous PCA)

    Time frame: 24 hours post-block

    Total amount of hydromorphone consumed within 24 hours post-block

  5. Total hydromorphone used (oral and intravenous PCA)

    Time frame: 48 hours post-block

    Total amount of hydromorphone consumed within 48 hours post-block

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 20, 2017
Registry last updated
Apr 28, 2017

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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