ArthritisNCT01290185
Coiled Catheters for Regional Anesthesia
A study testing Placement of different catheters for continuous nerve block in people with Arthritis, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic therapy. The successful use of continuous peripheral nerve blocks provides sustained analgesia while minimizing the need for opioid analgesics throughout the postoperative period and avoiding the side effects associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Placement of different catheters for continuous nerve block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Jun 2012
- 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
- Ability to provide informed consent, understanding of the possible local anaesthetic-related complications, and understanding of the study protocol.
Who cannot join
- Any contraindication to peripheral nerve block, allergy to local anaesthetics, infection near the insertion site, ASA classification IV or V, pregnancy, chronic opioid analgesic therapy (>30mg morphine equivalent per day), coagulopathy, known hepatic or renal insufficiency, peripheral neuropathy and patient refusal.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Health Sciences Centres, Holland Orthopedic and Arthritic Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Improving the Success Rate of Continuous Peripheral Nerve Blocks Using a Novel Coiled Catheter
Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic therapy. The successful use of continuous peripheral nerve blocks provides sustained analgesia while minimizing the need for opioid analgesics throughout the postoperative period and avoiding the side effects associated with central neuraxial techniques. Excellent analgesia can be maintained and opioid-related side effects avoided allowing improved rehabilitation. However using existing methods a failure rate of >20% significantly limits the analgesic benefits in a substantial proportion leading to uncontrolled pain and side effects of opioid analgesics.
A major concern with the use of continuous peripheral nerve blocks is difficulty in placement of the catheters close enough to the nerve to allow for effective local anaesthetic spread and therefore analgesia. The benefit of ultrasound to precisely place needles adjacent to nerves and increase efficacy of block success is undisputed. However ultrasound is of less help in accurately placing catheters. Indeed the final position of the catheter tip is not predictable and can be inadequate in 10%-50% of cases. The explanation for that is the material in currently used catheters is stiff and designed to avoid kinking. Unfortunately this same stiffness often leads to inadequate placement of the catheter tip. We have developed a catheter which coils up as soon as it is advanced beyond the needle tip, thus allowing the catheter tip to remain close to the initial needle tip position and therefore the nerve. The aim of this prospective randomized double blind controlled study is to determine the effectiveness of this new catheter in comparison with standard of care methods for continuous femoral nerve block commonly used after total knee arthroplasty. The primary outcome measure will be the incidence of catheter related block failure 24 hours after surgery. Our hypothesis is that the coiled catheter will significantly improve the efficacy of continuous femoral nerve block as compared to existing techniques.
Read the detailed description
Aims of the study The aim is to determine the effectiveness of a the coiled catheter for continuous peripheral nerve block after total knee arthroplasty based on secondary block failures compared to the secondary block failures of the conventional, currently used stimulating catheters.
Study design The trial is a prospective single-centre randomized double-blinded controlled trial. Patients will be randomized to (1) use of conventional stimulating catheters or (2) to use of a coiled catheter.
Patient population Adult patients of at least 18 years of age undergoing unilateral knee arthroplasty, under spinal anaesthesia will be recruited in this randomized double blind controlled trial.
Inclusion criteria: Ability to provide informed consent, understanding of the possible local anaesthetic-related complications, and understanding of the study protocol.
Exclusion criteria: Any contraindication to peripheral nerve block, allergy to local anaesthetics, infection near the insertion site, ASA classification IV or V, pregnancy, chronic opioid analgesic therapy (>30mg morphine equivalent per day), coagulopathy, known hepatic or renal insufficiency, peripheral neuropathy and patient refusal.
- Conditions
- Arthritis
- Being tested
- Placement of different catheters for continuous nerve block
- Keywords
- Arthroplasty, Pharmacol Nerve Block
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of different catheters for continuous nerve blockDevice
Also called Sonoline Curl Catheter Set, Pajunk, StimuCath; Arrow International
Placement different catheters adjacent to the femoral
| Study group | Role | What they receive |
|---|---|---|
| Coiled Catheter | Experimental | Placement of the coiled catheter for continuous infusion of local anesthetics close to the femoral nerve: To place coiled catheters ab 18-gauge Tuohy needle (Sonoline Curl Catheter Set, Pajunk® Medizintechnologie GmbH, Geisingen, Germany) of 8 cm length is placed adjacent to the nerve by ultrasound guidance and nerve stimulator control. At this position and after injection of 5 ml dextrose 5% in water to dilate the space the coiled catheter is blindly advanced 2 cm through the needle and the final position verified with ultrasound. Receives: Device: Placement of different catheters for continuous nerve block |
| Conventional stimulating Catheter | Active comparator | For the control group a conventional stimulating catheter is placed adjacent to the femoral nerve as follows: To place the simulating catheter an 18-gauge Tuhoy needle s placed adjacenit to the nerve by ultrasound guidance. At this position a stimulation catheter is introduced through the needle and stimulated with a decreasing current from 1 mA to 0.4 mA, with a pulse width 0.1ms to verify the appropriate motor response of the quadriceps muscle. The catheter is slowly advanced 3 cm beyond the needle tip under continuous electric stimulation using a current that is subsequently adapted according to the motor response achieved. If muscles twitches disappear during catheter placement at a current above 1 mA, either the catheter or the needle are manipulated until muscle twitches reappear. Receives: Device: Placement of different catheters for continuous nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary block failure rate
The primary outcome measure will be the presence or absence of analgesia (loss of temperature sensation in the femoral nerve distribution) on postoperative day 1 at 24 hours after placement of the catheter.
Secondary block failure rates are defined as presence of temperature sensation in the sensory distribution of the femoral nerve i.e.: anterior aspect of the thigh and anteromedial lower leg.
Measured: 24 hours after intervention (i.e. catheter placement)
Secondary outcomes (1)
Catheter placement
- Technical difficulty of catheter placement: a. Number of attempts to place the catheter. b. lowest nerve stimulator output current at the final position of the catheter.
- Total time taken to place the catheter.
- Primary block failures as evaluated during the first 20 minutes after injection of Mepivacaine 1% through the catheters; defined as only partial or absent sensory or motor block in the sensory distribution of the femoral nerve as is: anterior aspect of the thigh and strength of quadriceps muscle.
Measured: 1 Minute after Catheter placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies 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
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Cedric Luyet, Sunnybrook Health Sciences Centre
- Investigators
- Colin J McCartney, M.D., Study director, Sunnybrook Health Sciences Centres, TorontoCédric Luyet, M.D., Principal investigator, Sunnybrook Health Sciences Centres, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290185
- Sponsor's protocol ID
- Luyet Coiled Catheters
- Status last verified
- Jun 2012
- First submitted
- 31 Jan 2011
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Luyet C, Seiler R, Herrmann G, Hatch GM, Ross S, Eichenberger U. Newly designed, self-coiling catheters for regional anesthesia--an imaging study. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):171-6. doi: 10.1097/AAP.0b013e31820d431a.
PubMed 21270719
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Success Rate of Continuous Peripheral Nerve Blocks Using a Novel Coiled Catheter
- ClinicalTrials.gov ID
- NCT01290185
- Acronym / sponsor ID
- Luyet Coiled Catheters
- Conditions
- Arthritis
- Keywords
- Arthroplasty, Pharmacol Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Feb 2011 (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.
Major orthopaedic surgery is painful and requires safe and effective postoperative analgesic therapy. The successful use of continuous peripheral nerve blocks provides sustained analgesia while minimizing the need for opioid analgesics throughout the postoperative period and avoiding the side effects associated with central neuraxial techniques. Excellent analgesia can be maintained and opioid-related side effects avoided allowing improved rehabilitation. However using existing methods a failure rate of >20% significantly limits the analgesic benefits in a substantial proportion leading to uncontrolled pain and side effects of opioid analgesics.
A major concern with the use of continuous peripheral nerve blocks is difficulty in placement of the catheters close enough to the nerve to allow for effective local anaesthetic spread and therefore analgesia. The benefit of ultrasound to precisely place needles adjacent to nerves and increase efficacy of block success is undisputed. However ultrasound is of less help in accurately placing catheters. Indeed the final position of the catheter tip is not predictable and can be inadequate in 10%-50% of cases. The explanation for that is the material in currently used catheters is stiff and designed to avoid kinking. Unfortunately this same stiffness often leads to inadequate placement of the catheter tip. We have developed a catheter which coils up as soon as it is advanced beyond the needle tip, thus allowing the catheter tip to remain close to the initial needle tip position and therefore the nerve. The aim of this prospective randomized double blind controlled study is to determine the effectiveness of this new catheter in comparison with standard of care methods for continuous femoral nerve block commonly used after total knee arthroplasty. The primary outcome measure will be the incidence of catheter related block failure 24 hours after surgery. Our hypothesis is that the coiled catheter will significantly improve the efficacy of continuous femoral nerve block as compared to existing techniques.
Detailed description
Aims of the study The aim is to determine the effectiveness of a the coiled catheter for continuous peripheral nerve block after total knee arthroplasty based on secondary block failures compared to the secondary block failures of the conventional, currently used stimulating catheters.
Study design The trial is a prospective single-centre randomized double-blinded controlled trial. Patients will be randomized to (1) use of conventional stimulating catheters or (2) to use of a coiled catheter.
Patient population Adult patients of at least 18 years of age undergoing unilateral knee arthroplasty, under spinal anaesthesia will be recruited in this randomized double blind controlled trial.
Inclusion criteria: Ability to provide informed consent, understanding of the possible local anaesthetic-related complications, and understanding of the study protocol.
Exclusion criteria: Any contraindication to peripheral nerve block, allergy to local anaesthetics, infection near the insertion site, ASA classification IV or V, pregnancy, chronic opioid analgesic therapy (>30mg morphine equivalent per day), coagulopathy, known hepatic or renal insufficiency, peripheral neuropathy and patient refusal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coiled Catheter | Experimental | Device: Placement of different catheters for continuous nerve blockPlacement of the coiled catheter for continuous infusion of local anesthetics close to the femoral nerve: To place coiled catheters ab 18-gauge Tuohy needle (Sonoline Curl Catheter Set, Pajunk® Medizintechnologie GmbH, Geisingen, Germany) of 8 cm length is placed adjacent to the nerve by ultrasound guidance and nerve stimulator control. At this position and after injection of 5 ml dextrose 5% in water to dilate the space the coiled catheter is blindly advanced 2 cm through the needle and the final position verified with ultrasound. |
| Conventional stimulating Catheter | Active comparator | Device: Placement of different catheters for continuous nerve blockFor the control group a conventional stimulating catheter is placed adjacent to the femoral nerve as follows: To place the simulating catheter an 18-gauge Tuhoy needle s placed adjacenit to the nerve by ultrasound guidance. At this position a stimulation catheter is introduced through the needle and stimulated with a decreasing current from 1 mA to 0.4 mA, with a pulse width 0.1ms to verify the appropriate motor response of the quadriceps muscle. The catheter is slowly advanced 3 cm beyond the needle tip under continuous electric stimulation using a current that is subsequently adapted according to the motor response achieved. If muscles twitches disappear during catheter placement at a current above 1 mA, either the catheter or the needle are manipulated until muscle twitches reappear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ability to provide informed consent, understanding of the possible local anaesthetic-related complications, and understanding of the study protocol.
Key exclusion criteria (1 listed)
- Any contraindication to peripheral nerve block, allergy to local anaesthetics, infection near the insertion site, ASA classification IV or V, pregnancy, chronic opioid analgesic therapy (>30mg morphine equivalent per day), coagulopathy, known hepatic or renal insufficiency, peripheral neuropathy and patient refusal.
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 |
|---|---|---|
| Placement of different catheters for continuous nerve blockAlso: Sonoline Curl Catheter Set, Pajunk, StimuCath; Arrow InternationalPlacement different catheters adjacent to the femoral | Device | Coiled Catheter, Conventional stimulating Catheter |
Primary outcome
Secondary block failure rate
Time frame: 24 hours after intervention (i.e. catheter placement)
The primary outcome measure will be the presence or absence of analgesia (loss of temperature sensation in the femoral nerve distribution) on postoperative day 1 at 24 hours after placement of the catheter. Secondary block failure rates are defined as presence of temperature sensation in the sensory distribution of the femoral nerve i.e.: anterior aspect of the thigh and anteromedial lower leg.
1 secondary outcome
Catheter placement
Time frame: 1 Minute after Catheter placement
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 28 Jun 2012.
- Background: PubMed 21270719Luyet C, Seiler R, Herrmann G, Hatch GM, Ross S, Eichenberger U. Newly designed, self-coiling catheters for regional anesthesia--an imaging study. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):171-6. doi: 10.1097/AAP.0b013e31820d431a.
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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.
Colin J McCartney, M.D. study director
Sunnybrook Health Sciences Centres, Toronto
Cédric Luyet, M.D. principal investigator
Sunnybrook Health Sciences Centres, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of different catheters for continuous nerve block in people with Arthritis, 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 1 inclusion and 1 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 Jun 2012. 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?
Secondary block failure rate (time frame: 24 hours after intervention (i.e. catheter placement)). 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 NCT01290185, 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 28 Jun 2012.