Nerve BlockPhase 4NCT02431858
Catheter Over Needle vs Catheter Through Needle
A Phase 4 study testing E-Catheter (Pajunk) and Sonolong Catheter (Pajunk) in people with Nerve Block and Catheterization, run by Sir Charles Gairdner Hospital at 1 site in Australia.
Trial summary
To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block, Catheterization
- What is being tested?
- E-Catheter (Pajunk) and Sonolong Catheter (Pajunk)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteAustralia
- Study dates
- May 2015to Feb 2016
- Phase
- Phase 4
- 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 presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary total knee replacement.
- Body mass index 18-40 kg/m2
- American Society of Anaesthetists (ASA) grade I-III
Who cannot join
- Allergy to local anaesthetic
- Inability to cooperate
- Inability to read, speak and understand English
- Less than 18 years old
Trial locations and contacts
1 site in 1 country.
Australia1 site
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
About this study
Official title: Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.
Read the detailed description
Background: Total Knee Replacement Surgery is a commonly performed procedure that causes significant post-operative pain. Continuous femoral nerve blocks are widely used for analgesia as part of a multimodal analgesic regimen for this surgery. They provide sustained analgesia which allows early physiotherapy for rehabilitation. Currently the most common technique for inserting catheters for continuous femoral nerve blocks is to feed a catheter though a needle (CTN) which has been placed close by the nerve. There is a significant rate of leak and dislodgement of these catheters which can lead secondary failure where the catheter is no longer providing analgesia by blocking the nerve (primary failure occurs when the nerve block catheter fails to provide any analgesia from the start). The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn. The proposed benefit of this is that there will be a reduction in leak rates and dislodgement. This is because using a CON technique means that the biggest hole will be the diameter of the catheter, rather than CTN where the biggest hole will be the diameter of the needle therefore allowing leak around the outside of the catheter.
Objectives: To ascertain whether or not the catheter over needle technique is superior to catheter through needle technique in terms of a leak rate.
Trial plan: To recruit 108 patients who are having total knee replacement surgery into the study and randomise them into having either CON or CTN continuous femoral nerve blocks.
- Conditions
- Nerve Block, Catheterization
- Being tested
- E-Catheter (Pajunk), Sonolong Catheter (Pajunk)
- Keywords
- Nerve block, Catheter, Catheter over needle, Femoral Nerve, Anaesthesia, [E04.525.210.550], [E02.148]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Catheter (Pajunk)Device
Also called Australian Therapeutic Goods Registry (ATGR) no: 133630
Sonolong Catheter (Pajunk)Device
Also called Australian Therapeutic Goods Registry (ATGR) no: 133630
| Study group | Role | What they receive |
|---|---|---|
| Catheter Over Needle | Experimental | The femoral nerve catheter used will be the "E-Catheter" (Pajunk) device which is a novel catheter over needle system. Receives: Device: E-Catheter (Pajunk) |
| Catheter through needle | Active comparator | The femoral nerve catheter used will be the "Sonolong" catheter (Pajunk) which is a traditional catheter through needle system. Receives: Device: Sonolong Catheter (Pajunk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter leakage
Any leakage around the catheter insertion site as assessed by visual inspection.
Measured: 2 days post insertion
Secondary outcomes (3)
Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op.
Secondary failure is when a nerve catheter that was previously working has ceased to provide analgesia.
Measured: 2 days
Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale.
Assess the anaesthetist's opinion on the ease of insertion of the different catheters
Measured: intraoperative
Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.
Assessing the needle visibility in the two different catheter systems.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Charles Gairdner Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Edwards, Sir Charles Gairdner Hospital
- Investigators
- Richard M Edwards, MBBS, Principal investigator, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431858
- Sponsor's protocol ID
- 2015-011
- Status last verified
- Apr 2016
- First submitted
- 22 Apr 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT02431858
- Acronym / sponsor ID
- 2015-011
- Conditions
- Nerve Block, Catheterization
- Keywords
- Nerve block, Catheter, Catheter over needle, Femoral Nerve, Anaesthesia, [E04.525.210.550], [E02.148]
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sir Charles Gairdner HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 May 2015 (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.
To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.
Detailed description
Background: Total Knee Replacement Surgery is a commonly performed procedure that causes significant post-operative pain. Continuous femoral nerve blocks are widely used for analgesia as part of a multimodal analgesic regimen for this surgery. They provide sustained analgesia which allows early physiotherapy for rehabilitation. Currently the most common technique for inserting catheters for continuous femoral nerve blocks is to feed a catheter though a needle (CTN) which has been placed close by the nerve. There is a significant rate of leak and dislodgement of these catheters which can lead secondary failure where the catheter is no longer providing analgesia by blocking the nerve (primary failure occurs when the nerve block catheter fails to provide any analgesia from the start). The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn. The proposed benefit of this is that there will be a reduction in leak rates and dislodgement. This is because using a CON technique means that the biggest hole will be the diameter of the catheter, rather than CTN where the biggest hole will be the diameter of the needle therefore allowing leak around the outside of the catheter.
Objectives: To ascertain whether or not the catheter over needle technique is superior to catheter through needle technique in terms of a leak rate.
Trial plan: To recruit 108 patients who are having total knee replacement surgery into the study and randomise them into having either CON or CTN continuous femoral nerve blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Over Needle | Experimental | Device: E-Catheter (Pajunk)The femoral nerve catheter used will be the "E-Catheter" (Pajunk) device which is a novel catheter over needle system. |
| Catheter through needle | Active comparator | Device: Sonolong Catheter (Pajunk)The femoral nerve catheter used will be the "Sonolong" catheter (Pajunk) which is a traditional catheter through needle system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary total knee replacement.
- Body mass index 18-40 kg/m2
- American Society of Anaesthetists (ASA) grade I-III
Key exclusion criteria (4 listed)
- Allergy to local anaesthetic
- Inability to cooperate
- Inability to read, speak and understand English
- Less than 18 years old
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 |
|---|---|---|
| E-Catheter (Pajunk)Also: Australian Therapeutic Goods Registry (ATGR) no: 133630 | Device | Catheter Over Needle |
| Sonolong Catheter (Pajunk)Also: Australian Therapeutic Goods Registry (ATGR) no: 133630 | Device | Catheter through needle |
Primary outcome
Catheter leakage
Time frame: 2 days post insertion
Any leakage around the catheter insertion site as assessed by visual inspection.
3 secondary outcomes
Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op.
Time frame: 2 days
Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale.
Time frame: intraoperative
Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
Related trials for Nerve Block
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Not yet recruiting
Anesthetic Effectiveness of Mental/Incisive Nerve Block Versus Inferior Nerve Block Using 4% Articaine and 2% Lidocaine in Mandibular First and Second Premolars With Symptomatic Irreversible Pulpitis.
Pain
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
Anaesthetic Requirements During Total Hip Arthroplasty
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
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.
Richard M Edwards, MBBS principal investigator
Sir Charles Gairdner Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E-Catheter (Pajunk) and Sonolong Catheter (Pajunk) in people with Nerve Block and Catheterization, run by Sir Charles Gairdner Hospital at 1 site in Australia.
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 3 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 19 Apr 2016. 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 Australia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Catheter leakage (time frame: 2 days post insertion). 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 Apr 2016.