NCT03121976

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

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

January 2, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

April 4, 2017

Last Update Submit

April 26, 2017

Conditions

AnesthesiaPainNerve PainKnee ArthroplastyNerve Block

Outcome Measures

Primary Outcomes (1)

  • Mean numeric pain score (NRS)

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

    24 hours post-block insertion

Secondary Outcomes (5)

  • Time to perform the block

    At the time of block procedure

  • Sensation over the skin of the thigh to determine sensory block using 3 point grading scale

    30 min post-block insertion

  • Quadriceps muscle strength to determine motor block using 3 point grading scale

    30 min post-block insertion

  • Total hydromorphone used (oral and intravenous PCA)

    24 hours post-block

  • Total hydromorphone used (oral and intravenous PCA)

    48 hours post-block

Study Arms (2)

Ultrasound

EXPERIMENTAL

Femoral catheters inserted using ultrasound only

Device: Ultrasound

Ultrasound + Nerve Stimulation

ACTIVE COMPARATOR

Femoral catheters inserted using ultrasound with nerve stimulation

Device: Ultrasound + Nerve Stimulation

Interventions

UltrasoundDEVICE

Femoral catheter inserted using ultrasound only

Ultrasound
Ultrasound + Nerve StimulationDEVICE

Femoral catheter inserted using ultrasound and nerve stimulation

Ultrasound + Nerve Stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

Related Publications (10)

  • Pham Dang C, Lelong A, Guilley J, Nguyen JM, Volteau C, Venet G, Perrier C, Lejus C, Blanloeil Y. Effect on neurostimulation of injectates used for perineural space expansion before placement of a stimulating catheter: normal saline versus dextrose 5% in water. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):398-403. doi: 10.1097/AAP.0b013e3181b48648.

    PMID: 19920414BACKGROUND

  • Dauri M, Fabbi E, Mariani P, Faria S, Carpenedo R, Sidiropoulou T, Coniglione F, Silvi MB, Sabato AF. Continuous femoral nerve block provides superior analgesia compared with continuous intra-articular and wound infusion after anterior cruciate ligament reconstruction. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):95-9. doi: 10.1097/AAP.0b013e31819baf98.

    PMID: 19282706BACKGROUND

  • Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.

    PMID: 20966667BACKGROUND

  • Shum CF, Lo NN, Yeo SJ, Yang KY, Chong HC, Yeo SN. Continuous femoral nerve block in total knee arthroplasty: immediate and two-year outcomes. J Arthroplasty. 2009 Feb;24(2):204-9. doi: 10.1016/j.arth.2007.09.014. Epub 2008 Mar 4.

    PMID: 18534496BACKGROUND

  • Carli F, Clemente A, Asenjo JF, Kim DJ, Mistraletti G, Gomarasca M, Morabito A, Tanzer M. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth. 2010 Aug;105(2):185-95. doi: 10.1093/bja/aeq112. Epub 2010 Jun 14.

    PMID: 20551021BACKGROUND

  • Salinas FV, Liu SS, Mulroy MF. The effect of single-injection femoral nerve block versus continuous femoral nerve block after total knee arthroplasty on hospital length of stay and long-term functional recovery within an established clinical pathway. Anesth Analg. 2006 Apr;102(4):1234-9. doi: 10.1213/01.ane.0000198675.20279.81.

    PMID: 16551930BACKGROUND

  • Boezaart AP, de Beer JF, du Toit C, van Rooyen K. A new technique of continuous interscalene nerve block. Can J Anaesth. 1999 Mar;46(3):275-81. doi: 10.1007/BF03012610.

    PMID: 10210055BACKGROUND

  • Martinez Navas A, Vazquez Gutierrez T, Echevarria Moreno M. Continuous lateral popliteal block with stimulating catheters. Acta Anaesthesiol Scand. 2005 Feb;49(2):261-3. doi: 10.1111/j.1399-6576.2004.00574.x.

    PMID: 15715632BACKGROUND

  • Casati A, Fanelli G, Koscielniak-Nielsen Z, Cappelleri G, Aldegheri G, Danelli G, Fuzier R, Singelyn F. Using stimulating catheters for continuous sciatic nerve block shortens onset time of surgical block and minimizes postoperative consumption of pain medication after halux valgus repair as compared with conventional nonstimulating catheters. Anesth Analg. 2005 Oct;101(4):1192-1197. doi: 10.1213/01.ane.0000167232.10305.cd.

    PMID: 16192543BACKGROUND

  • Cappelleri G, Ghisi D, Ceravola E, Guzzetti L, Ambrosoli AL, Gemma M, Cornaggia G. A randomised controlled comparison between stimulating and standard catheters for lumbar plexus block. Anaesthesia. 2015 Aug;70(8):948-55. doi: 10.1111/anae.13077. Epub 2015 Mar 21.

    PMID: 25810108BACKGROUND

MeSH Terms

Conditions

PainNeuralgia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Imad Awad, MBChB

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 20, 2017

Study Start

January 2, 2012

Primary Completion

December 31, 2012

Study Completion

March 31, 2013

Last Updated

April 28, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)