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AnesthesiaNCT03121976

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

A study testing Ultrasound and Ultrasound + Nerve Stimulation in people with Anesthesia and Pain, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anesthesia, Pain, Nerve Pain
What is being tested?
Ultrasound and Ultrasound + Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteCanada
Study dates
2 Jan 2012to 31 Mar 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4Y 1H1

Other trials in Canada

About this study

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

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.

Read the 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.

Being tested
Ultrasound, Ultrasound + Nerve Stimulation
Medical subject headings
Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    Femoral catheter inserted using ultrasound only

  • Ultrasound + Nerve StimulationDevice

    Femoral catheter inserted using ultrasound and nerve stimulation

Study groups in NCT03121976
Study groupRoleWhat they receive
UltrasoundExperimentalFemoral catheters inserted using ultrasound only
Receives: Device: Ultrasound
Ultrasound + Nerve StimulationActive comparatorFemoral catheters inserted using ultrasound with nerve stimulation
Receives: Device: Ultrasound + Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean numeric pain score (NRS)

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

    Measured: 24 hours post-block insertion

Secondary outcomes (5)

  1. Time to perform the block

    Time required to perform the block procedure

    Measured: At the time of block procedure

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

    Sensory block evaluation examined the sensation over the skin of the thigh

    Measured: 30 min post-block insertion

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

    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°

    Measured: 30 min post-block insertion

  4. Total hydromorphone used (oral and intravenous PCA)

    Total amount of hydromorphone consumed within 24 hours post-block

    Measured: 24 hours post-block

  5. Total hydromorphone used (oral and intravenous PCA)

    Total amount of hydromorphone consumed within 48 hours post-block

    Measured: 48 hours post-block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2017
  2. Study start2 Jan 2012
  3. Primary completion31 Dec 2012
  4. Study completion31 Mar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121976
Sponsor's protocol ID
373-2011
Status last verified
Apr 2017
First submitted
4 Apr 2017
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19920414

  • 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.

    PubMed 19282706

  • 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.

    PubMed 20966667

  • 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.

    PubMed 18534496

  • 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.

    PubMed 20551021

  • 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.

    PubMed 16551930

  • 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.

    PubMed 10210055

  • 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.

    PubMed 15715632

  • 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.

    PubMed 16192543

  • 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.

    PubMed 25810108

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound and Ultrasound + Nerve Stimulation in people with Anesthesia and Pain, run by Sunnybrook Health Sciences Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean numeric pain score (NRS) (time frame: 24 hours post-block insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03121976, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.

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