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Osteoarthritis KneePhase 3Echostim1NCT01492660

Echogenic Versus Stimulating Needle and Catheter for Sciatic Blocks

A Phase 3 study testing echogenic needle and catheter and Neurostimulation to position needle and catheter in people with Osteoarthritis Knee and Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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

Patients scheduled for total knee replacements and suitable for sciatic nerve block will be randomized to one of 2 groups. Group 1 will have the nerve block performed using a standard Pajunk block needle under ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement also guided by… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Osteoarthritis Knee, Postoperative Pain
What is being tested?
echogenic needle and catheter and Neurostimulation to position needle and catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteCanada
Study dates
Jan 2012to Jan 2013
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients age 18-80 years listed for total knee arthroplasty.
  • ASA I-IV.
  • Able to give informed consent
  • Able to cooperate with study protocol.

Who cannot join

  • Standard contraindication to regional anaesthesia/analgesia: local infection, coagulopathy, local anaesthetic allergy, patient refusal, diabetes mellitus, peripheral neuropathy, pre-existing nerve injury)
  • Inability to consent
  • Patient refusal
  • Pregnant patients

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • London Health Sciences Centre University Hospital

    London, Ontario, N6A 5A5

Other trials in Canada

About this study

Official title: Comparison of Visibility of Echogenic and Standard Non-echogenic Block Needles During Ultrasound Guided Sciatic Blocks. A Randomized Prospective Study

Patients scheduled for total knee replacements and suitable for sciatic nerve block will be randomized to one of 2 groups.

Group 1 will have the nerve block performed using a standard Pajunk block needle under ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement also guided by electrical nerve stimulation. Group 2 will have the block performed using a Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for catheter location.

An observer blinded to the needle type will assess the quality of needle visualisation on a recording of the US image taken during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate, block performance time, complication rate, number of needle passes per block, and adequacy of spread of local anesthetic.

Read the detailed description

A total of 70 patients with ASA physical status 1 to 4, scheduled for elective total knee arthroplasty and deemed suitable to receive a sciatic nerve block will be included in the study. They will be randomised to one of two groups prior to the block procedure using a closed envelope system.

Recruitment will take place in the preoperative clinic. All blocks will be performed in the block room using standard monitoring, sterile precautions and titrated intravenous sedation.

Prior to the sciatic nerve block a continuous femoral nerve block will be performed according to standard procedure. Once this is complete the patient will be positioned for the sciatic nerve block.

A preprocedural scan will be done as per standard practice and skin will be infiltrated with 1% lidocaine.

The anaesthetist performing the block will be aware of the study group allocation due to the requirement for physically handling the block needles, and will proceed to position the needle into the required location site to facilitate catheter insertion, with the aid of electrical nerve stimulation via the needle. This will be recorded using the ultrasound machines cineloop facility.

If after 6 passes the operator is unable either to contact the nerve according to the ultrasound image or elicit a twitch response, the procedure will be abandoned and this will be considered a failed block. In this case analgesia will be covered with periarticular infiltration and opioids.

During needle positioning, the observer will record the number of needle redirections required to optimally locate the needle, each redirection being defined as every movement which follows a withdrawal of more than 2cm. The observer will also record the number of skin punctures required and any arterial or venous punctures.

Group E will have the block performed using the echogenic needle, and the echogenic catheter will be placed using ultrasound guidance.

The catheter will be inserted through the needle by a second anesthetist. This process will be continuously recording using the cineloop feature of the ultrasound machine. Once the catheter is deemed to be in an appropriate position, local anaesthetic will be injected by the second anaesthetist while observing the disposition of the local anaesthetic perineurally in short axis. This will be confirmed with a long axis view of the nerve (also recorded).

Group S will have the block performed with a standard needle and catheter, guided by electrical nerve stimulation.

Acceptable muscle twitch response will be plantar- or dorsiflexion, inversion or eversion with an initial nerve current strength of 0.5mA at a frequency of 2Hz. If a satisfactory motor response cannot be elicited, current will be increased in stages to 1.5mA. If a response still cannot be elicited this will be recorded but the catheter will still be used if its position is deemed satisfactory using colour Doppler - a medley of colour adjacent to the nerve with the injection of agitated dextrose 5%. Once the catheter is deemed to be in an appropriate position, local anaesthetic will be injected by the second anaesthetist while observing the disposition of the local anaesthetic perineurally in short axis. This will be confirmed with a long axis view of the nerve (also recorded).

Once the catheter has been sited using the above techniques, a bolus of agitated 5% dextrose will be injected through the catheter and Doppler ultrasound will be used to locate where in the tissues the injected fluid is being deposited. This will also be recorded and subsequently assessed.

An assistant present during the block will time two aspects of the procedure:

  1. Time from first skin contact with needle to first muscle response to nerve stimulation. This will be done only on the day of surgery during the block procedure until the desired muscle twitch is elicited.
  2. Time from first skin contact to completion of catheter insertion (Block time).This is done during the block procedure only on the day of surgery as noted above

Once catheter position has been assessed a total of 20 millilitres of 2% mepivacaine will be injected via the catheter in both groups. Over the subsequent 30 minutes a second blinded observer will take observations every 5 minutes to assess the degree of motor and sensory block.

The video recording of the block procedure will be sent along with the data collection form to two of the co-investigators, who will independently assess the following:

  1. At the time of nerve contact by the needle, assign a rating for visibility of the needle shaft and tip according to the following scale:
  2. not visualised or poorly visualised - needle tip/shaft being isoechoic or only slightly more echogenic than background parenchyma.
  3. tip or shaft visualised with some difficulty - tip/shaft readily identified as being more echogenic than the background parenchyma but not seen in their entirety
  4. excellent visibility shaft and tip strongly echogenic relative to tissue and visualised in their entirety.
  5. Assign the same rating after completion of injection
  6. Judge whether circumferential and longitudinal spread of local anaesthetic is either adequate or inadequate.

Following the operation a standard infusion of 0.1% ropivacaine at 4cc/hr will be commenced via the sciatic catheter. Post operative care will be as per the standard practice at this institution.

One week post operatively the patient will be telephoned at home to check for persisting neurological symptoms.

Being tested
echogenic needle and catheter, Neurostimulation to position needle and catheter
Keywords
Ultrasonography, nerve block, catheters, needle, anesthesia
Medical subject headings
Osteoarthritis, Knee, Pain, Postoperative

What participants receive

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

  • echogenic needle and catheterDevice

    Also called Pajunk Stimulong plexus catheter set, Pajunk sonolong sonoset

    Visibility of needle shaft and tip with engraved markers. Ultrasonographic Visibility of catheter tip

  • Neurostimulation to position needle and catheterDevice

    Also called Pajunk Stimulaong Plexus catheter set

    The non echogenic needle will be positioned using ultrasonography and neurostimulation and the catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. 20mL of 2% mepivacaine will be injected via the catheter. Sensory motor block will be evaluated every 5 minutes for 30 mins

Study groups in NCT01492660
Study groupRoleWhat they receive
Echogenic needle and catheterExperimentalThe echogenic needle will be positioned using ultrasonography and neurostimulation with an end point of plantar or dorsiflexion with 0.6mA of current strength. The catheter will be inserted using ultrasonography alone. 20 Ml of 2% mepivacaine will be inserted using the catheter. The distribution of drug will be evaluated using short axis and long axis views. Sensory motor block evaluation every 5 minutes for 30 minutes. Duration of block procedure, number of passes and success will be evaluated
Receives: Device: echogenic needle and catheter
NeurostimulationActive comparatorThe non echogenic needle will be positioned using ultrasonography and neurostimulation with plantar or dorsiflexion as the end point with 0.6mA current.The catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current.
Receives: Device: Neurostimulation to position needle and catheter

What is being measured

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

  1. Visibility of needle tip and catheter tip

    Needle tip visibility graded by blinded observers Catheter tip visibility graded by blinded observers

    Measured: Day 1

Secondary outcomes (5)
  1. number of needle passes

    The number of times the needle is withdrawn more than 2 cm and resited

    Measured: Day 1

  2. success rate of block

    Motor and sensory block will be evaluated on standard grading system every 5 minutes for 30 minutes post injection

    Measured: Day 1

  3. Block procedure time

    Time from needle insertion to the end of catheter insertion

    Measured: Day 1

  4. Immediate complications

    Vascular punctures, venous or arterial

    Measured: Day 1

  5. delayed complications

    telephone interview to elicit delayed neurologic symptoms

    Measured: One week after surgery/block

Timeline

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

  1. First posted15 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2013
  4. Study completionJan 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492660
Sponsor's protocol ID
R-11-495
Other IDs
17757
Acronym
Echostim1
Status last verified
Jan 2012
First submitted
11 Oct 2011
Last updated
23 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • Brookes J, Sondekoppam R, Armstrong K, Uppal V, Dhir S, Terlecki M, Ganapathy S. Comparative evaluation of the visibility and block characteristics of a stimulating needle and catheter vs an echogenic needle and catheter for sciatic nerve block with a low-frequency ultrasound probe. Br J Anaesth. 2015 Dec;115(6):912-9. doi: 10.1093/bja/aev351.

    PubMed 26582852

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing echogenic needle and catheter and Neurostimulation to position needle and catheter in people with Osteoarthritis Knee and Postoperative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 4 inclusion and 4 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 23 Apr 2013. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Visibility of needle tip and catheter tip (time frame: Day 1). 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 NCT01492660, which also lists 1 linked publication.

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 23 Apr 2013; AzTrials last refreshed its copy on 28 Oct 2026.

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