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

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT03121976
Collaborator
(none)
82
1
2
14.9
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ultrasound
  • Device: Ultrasound + Nerve Stimulation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Jan 2, 2012
Actual Primary Completion Date :
Dec 31, 2012
Actual Study Completion Date :
Mar 31, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mean numeric pain score (NRS) [24 hours post-block insertion]

    Pain score assessed 24 hours post-block insertion using numeric pain scale from 0-10

Secondary Outcome Measures

  1. Time to perform the block [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 [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 [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) [24 hours post-block]

    Total amount of hydromorphone consumed within 24 hours post-block

  5. Total hydromorphone used (oral and intravenous PCA) [48 hours post-block]

    Total amount of hydromorphone consumed within 48 hours post-block

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4Y 1H1

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Imad Awad, MBChB, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT03121976
Other Study ID Numbers:
  • 373-2011
First Posted:
Apr 20, 2017
Last Update Posted:
Apr 28, 2017
Last Verified:
Apr 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2017