Peripheral Nerve Block ProcedureEchoCathNCT02136446
Prospective Post-market Evaluation of an Echogenic Catheter
A study testing EchoGlo Nerve Block Catheter and Pajunk® Nerve Block Catheter in people with Peripheral Nerve Block Procedure, run by Smiths Medical, ASD, Inc. at 1 site in United Kingdom.
Trial summary
Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups. Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nerve Block Procedure
- What is being tested?
- EchoGlo Nerve Block Catheter and Pajunk® Nerve Block Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Oct 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
- Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
- Patients at least 18 years old
- Patient is willing and able to provide informed consent for study participation
- Patient has a good understanding of written and verbal English
Who cannot join
- Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
- Patient with known coagulopathy
- Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
- Patients having mastectomy and immediate reconstruction
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital
London, NW14 5BU
Simeon West, MBChB FRCA, +07919205965, simeon.west@nhs.net
About this study
Official title: Prospective Post-market Evaluation of an Echogenic Catheter Used in a Peripheral Nerve Block Procedure
Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups.
Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.
The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image 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 and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.
- Conditions
- Peripheral Nerve Block Procedure
- Being tested
- EchoGlo Nerve Block Catheter, Pajunk® Nerve Block Catheter
- Keywords
- Paravertebral block, Mastectomy, Post-operative pain, Echogenic, Peripheral nerve block catheter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoGlo Nerve Block CatheterDevice
Also called EchoGlo™ Peripheral Nerve Block Catheter
Catheter used for a paravertebral anesthesia block
Pajunk® Nerve Block CatheterDevice
Also called Pajunk® EpiLong Catheter
Nerve Block Catheter
| Study group | Role | What they receive |
|---|---|---|
| EchoGlo™ Peripheral Nerve Block Catheter | Experimental | Echogenic nerve block catheter (test) Receives: Device: EchoGlo Nerve Block Catheter |
| Pajunk® EpiLong Catheter | Active comparator | Non-echogenic nerve block catheter (control) Receives: Device: Pajunk® Nerve Block Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visibility of entire catheter length
Demonstrate superior ultrasound visibility of the entire length of the test catheter compared to the control, as graded by a blinded investigator
Measured: Day 1, time of procedure
Visibility of catheter tip
Demonstrate superior ultrasound visibility of the test catheter tip compared to the control, as graded by a blinded investigator
Measured: Day 1, time of procedure
Secondary outcomes (2)
Quality of the block
Mean rating of block quality as assessed by the clinician on a 4 point scale per treatment group
Measured: Day 1, time of procedure
Block failure rate
Number of failed blocks per treatment group
Measured: Day 1, time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Block ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smiths Medical, ASD, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter R Kratz, MS, Study director, Smiths Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136446
- Sponsor's protocol ID
- EchoCath
- Acronym
- EchoCath
- Status last verified
- May 2015
- First submitted
- 7 May 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post-market Evaluation of an Echogenic Catheter Used in a Peripheral Nerve Block Procedure
- ClinicalTrials.gov ID
- NCT02136446
- Acronym / sponsor ID
- EchoCath / EchoCath
- Conditions
- Peripheral Nerve Block Procedure
- Keywords
- Paravertebral block, Mastectomy, Post-operative pain, Echogenic, Peripheral nerve block catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Smiths Medical, ASD, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups.
Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.
The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image 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 and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EchoGlo™ Peripheral Nerve Block Catheter | Experimental | Device: EchoGlo Nerve Block CatheterEchogenic nerve block catheter (test) |
| Pajunk® EpiLong Catheter | Active comparator | Device: Pajunk® Nerve Block CatheterNon-echogenic nerve block catheter (control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
- Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
- Patients at least 18 years old
- Patient is willing and able to provide informed consent for study participation
- Patient has a good understanding of written and verbal English
Key exclusion criteria (4 listed)
- Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
- Patient with known coagulopathy
- Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
- Patients having mastectomy and immediate reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchoGlo Nerve Block CatheterAlso: EchoGlo™ Peripheral Nerve Block CatheterCatheter used for a paravertebral anesthesia block | Device | EchoGlo™ Peripheral Nerve Block Catheter |
| Pajunk® Nerve Block CatheterAlso: Pajunk® EpiLong CatheterNerve Block Catheter | Device | Pajunk® EpiLong Catheter |
Primary outcome
Visibility of entire catheter length
Time frame: Day 1, time of procedure
Demonstrate superior ultrasound visibility of the entire length of the test catheter compared to the control, as graded by a blinded investigator
Visibility of catheter tip
Time frame: Day 1, time of procedure
Demonstrate superior ultrasound visibility of the test catheter tip compared to the control, as graded by a blinded investigator
2 secondary outcomes
Quality of the block
Time frame: Day 1, time of procedure
Block failure rate
Time frame: Day 1, time of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter R Kratz, MS study director
Smiths Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EchoGlo Nerve Block Catheter and Pajunk® Nerve Block Catheter in people with Peripheral Nerve Block Procedure, run by Smiths Medical, ASD, Inc. at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 19 May 2015. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simeon West, MBChB FRCA (+07919205965, simeon.west@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visibility of entire catheter length (time frame: Day 1, time of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2015.