Local AnesthesiaNCT01522053
Catheter-over-needle: Inpatient Study
A study testing Catheter-over-needle and Catheter-through-needle in people with Local Anesthesia and Catheterization, run by University of Alberta at 1 site in Canada.
Trial summary
When anesthesiologists perform a regional nerve block, they will often put a catheter - a flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic. This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Local Anesthesia, Catheterization
- What is being tested?
- Catheter-over-needle and Catheter-through-needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 yrs)
- Scheduled for surgery that requires continuous peripheral nerve block
Who cannot join
- Failure to provide informed consent
- Allergy to local anesthetic
- Neurological pathology and/or deficit in the block region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Catheter-over-needle and Catheter-through-needle Methods for Continuous Delivery of Local Anesthetic During Peripheral Nerve Blockade
When anesthesiologists perform a regional nerve block, they will often put a catheter - a flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic. This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and after surgery. The most common method of placing the catheter close to a nerve involves threading the catheter through a needle which has been inserted under the skin. Because the catheter is very thin and flexible, it does not thread well through tissue and will buckle and kink when enough force is applied to it. Another problem is that the puncture hole left by the needle is larger than the diameter of the catheter, meaning that when the needle is withdrawn, the catheter is not secure, which increases the chance that it will dislodge and cause leakage of local anesthetic. One solution to these problems is to use a catheter placement method similar to how intravenous catheters are installed. In this method, the catheter fits around ('over') the needle, which results in more support for the catheter while it is being pushed under the skin. We wish to examine if a catheter-over-needle method would be useful for placing a catheter to deliver local anesthetic during peripheral nerve blockade. We will compare the catheter-over-needle method to the currently used catheter-through-needle method on patients who require continuous anesthetic delivery for their surgery; half the patients will receive anesthetic through one method, and the other half will receive anesthetic through the other method. We believe that using the catheter-over-needle method will result in more secure placement of the catheter and more efficient delivery of local anesthetic.
Read the detailed description
Background: Current needle-catheter assemblies are designed so that a flexible catheter is threaded through a larger diameter needle towards a target nerve. These catheter-through-needle (CTN) assemblies suffer from several fundamental problems, including leakage at the insertion site and dislodgement of the catheter. The underlying problem of this design is that the needle puncture hole is wider in diameter than the catheter diameter. An alternative catheter-over-needle (CON) design, in which the catheter diameter is larger than that of the needle puncture hole, may be a potential solution to the problems of leakage and dislodgement. We wish to evaluate the ease of use and effectiveness of the CON method in the clinical setting by having anesthesiologists perform and rate the two techniques during and after administration of local anesthesia at various block sites on the body.
Study objective: To compare the ease of use and effectiveness of the CON technique to the CTN method in delivering continuous local anesthesia during regional nerve blockade.
Hypothesis: Insertion of a CON assembly catheter will result in more secure and accurate catheter placement and more efficient delivery of local anesthetic compared to a catheter placed using the CTN method.
Primary outcomes:
- Time taken to place catheter near target nerve after initial skin puncture.
- Confidence in accurate catheter placement.
- Assessment of catheter stability at insertion site.
- Incidence of anesthetic/fluid leakage at catheter insertion site.
Study procedures: This study will involve recruiting patients who are scheduled to undergo surgery that requires a regional nerve block via local anesthetic delivery through a perineural catheter. We wish to compare the CON and CTN catheterization methods for delivering local anesthetic during common regional blocks. One hundred patients will be recruited to assess the usefulness of the CON method in delivering local anesthetic. Patients in the study group will receive a continuous infusion of local anesthetic through a CON catheter. Patients in the control group will receive continuous local anesthetic through a CTN catheter. To make data collection easier, we will perform assessments at several locations in the Edmonton zone; anesthesiologists at each location will be asked to participate in performing the blocks and record their assessment of the two catheterization methods.
On the day of surgery, patients will be taken to the regional block area, where they will be positioned appropriately for the block they are to receive. Under ultrasound guidance, the attending anesthesiologist will install either the CON or CTN catheter. Each CTN catheter will be inserted as per standard procedures; CON catheters will be inserted in a similar fashion to that used for intravenous catheters. The anesthesiologist will be given Part 1 of a survey to evaluate the catheterization technique. On this survey, they will record the duration of time from initial skin puncture to placement of the end of the catheter near the target nerve and provide a subjective evaluation of how confident they are in the accuracy of the catheter's placement. Following connection of a continuous infusion of local anesthetic, the anesthesiologist will record an assessment of catheter stability and incidence of anesthetic leakage around the catheter insertion site.
During the postoperative period, the anesthesiologist will complete Part 2 of the assessment survey, which will record their personal opinion on the CON method's ease of use and its value in the clinical setting.
Inclusion criteria: Adult; scheduled for surgery that requires peripheral nerve blockade
Exclusion criteria: Failure to provide informed consent; allergy to local anesthetic; neurological pathology and/or deficit in the block region.
- Conditions
- Local Anesthesia, Catheterization
- Being tested
- Catheter-over-needle, Catheter-through-needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter-over-needleProcedure or surgery
Patients in the experimental group will receive a perineural catheter placed by the catheter-over-needle method.
Catheter-through-needleProcedure or surgery
Patients in the control group will receive a perineural catheter placed by the traditional catheter-though-needle method.
| Study group | Role | What they receive |
|---|---|---|
| Catheter-over-needle | Experimental | Patients will receive a catheter placed by a catheter-over-needle method. Receives: Procedure: Catheter-over-needle |
| Catheter-through-needle | Active comparator | Patients will receive a catheter placed by the traditional catheter-though-needle method. Receives: Procedure: Catheter-through-needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anesthetic/fluid leakage at catheter insertion site.
Evidence of leakage of local anesthetic at the catheter insertion site and any catheter dislodgement or premature withdrawal will be recorded.
Measured: Duration of time that perineural catheter is in the patient
Secondary outcomes (2)
Confidence in accurate catheter placement.
A subjective assessment of the catheterization and local anesthetic delivery technique will be provided by the anesthesiologist.
Measured: Duration of catheter placement in patient.
Time taken to place catheter near target nerve after initial skin puncture.
The time (in seconds) taken to correctly place the needle/catheter for delivery of local anesthetic will be recorded.
Measured: From identification of needle insertion site to correct placement of needle in patient; approximately 2 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionJan 2016
Why it stopped: PI no longer at institution
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 Local AnesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522053
- Sponsor's protocol ID
- Pro000027409
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2012
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ip VH, Rockley MC, Tsui BC. The catheter-over-needle assembly offers greater stability and less leakage compared with the traditional counterpart in continuous interscalene nerve blocks: a randomized patient-blinded study. Can J Anaesth. 2013 Dec;60(12):1272-3. doi: 10.1007/s12630-013-0032-6. Epub 2013 Sep 17. No abstract available.
PubMed 24043379
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Catheter-over-needle and Catheter-through-needle Methods for Continuous Delivery of Local Anesthetic During Peripheral Nerve Blockade
- ClinicalTrials.gov ID
- NCT01522053
- Acronym / sponsor ID
- Pro000027409
- Conditions
- Local Anesthesia, Catheterization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI no longer at institution
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Jan 2012 (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.
When anesthesiologists perform a regional nerve block, they will often put a catheter - a flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic. This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and after surgery. The most common method of placing the catheter close to a nerve involves threading the catheter through a needle which has been inserted under the skin. Because the catheter is very thin and flexible, it does not thread well through tissue and will buckle and kink when enough force is applied to it. Another problem is that the puncture hole left by the needle is larger than the diameter of the catheter, meaning that when the needle is withdrawn, the catheter is not secure, which increases the chance that it will dislodge and cause leakage of local anesthetic. One solution to these problems is to use a catheter placement method similar to how intravenous catheters are installed. In this method, the catheter fits around ('over') the needle, which results in more support for the catheter while it is being pushed under the skin. We wish to examine if a catheter-over-needle method would be useful for placing a catheter to deliver local anesthetic during peripheral nerve blockade. We will compare the catheter-over-needle method to the currently used catheter-through-needle method on patients who require continuous anesthetic delivery for their surgery; half the patients will receive anesthetic through one method, and the other half will receive anesthetic through the other method. We believe that using the catheter-over-needle method will result in more secure placement of the catheter and more efficient delivery of local anesthetic.
Detailed description
Background: Current needle-catheter assemblies are designed so that a flexible catheter is threaded through a larger diameter needle towards a target nerve. These catheter-through-needle (CTN) assemblies suffer from several fundamental problems, including leakage at the insertion site and dislodgement of the catheter. The underlying problem of this design is that the needle puncture hole is wider in diameter than the catheter diameter. An alternative catheter-over-needle (CON) design, in which the catheter diameter is larger than that of the needle puncture hole, may be a potential solution to the problems of leakage and dislodgement. We wish to evaluate the ease of use and effectiveness of the CON method in the clinical setting by having anesthesiologists perform and rate the two techniques during and after administration of local anesthesia at various block sites on the body.
Study objective: To compare the ease of use and effectiveness of the CON technique to the CTN method in delivering continuous local anesthesia during regional nerve blockade.
Hypothesis: Insertion of a CON assembly catheter will result in more secure and accurate catheter placement and more efficient delivery of local anesthetic compared to a catheter placed using the CTN method.
Primary outcomes:
- Time taken to place catheter near target nerve after initial skin puncture.
- Confidence in accurate catheter placement.
- Assessment of catheter stability at insertion site.
- Incidence of anesthetic/fluid leakage at catheter insertion site.
Study procedures: This study will involve recruiting patients who are scheduled to undergo surgery that requires a regional nerve block via local anesthetic delivery through a perineural catheter. We wish to compare the CON and CTN catheterization methods for delivering local anesthetic during common regional blocks. One hundred patients will be recruited to assess the usefulness of the CON method in delivering local anesthetic. Patients in the study group will receive a continuous infusion of local anesthetic through a CON catheter. Patients in the control group will receive continuous local anesthetic through a CTN catheter. To make data collection easier, we will perform assessments at several locations in the Edmonton zone; anesthesiologists at each location will be asked to participate in performing the blocks and record their assessment of the two catheterization methods.
On the day of surgery, patients will be taken to the regional block area, where they will be positioned appropriately for the block they are to receive. Under ultrasound guidance, the attending anesthesiologist will install either the CON or CTN catheter. Each CTN catheter will be inserted as per standard procedures; CON catheters will be inserted in a similar fashion to that used for intravenous catheters. The anesthesiologist will be given Part 1 of a survey to evaluate the catheterization technique. On this survey, they will record the duration of time from initial skin puncture to placement of the end of the catheter near the target nerve and provide a subjective evaluation of how confident they are in the accuracy of the catheter's placement. Following connection of a continuous infusion of local anesthetic, the anesthesiologist will record an assessment of catheter stability and incidence of anesthetic leakage around the catheter insertion site.
During the postoperative period, the anesthesiologist will complete Part 2 of the assessment survey, which will record their personal opinion on the CON method's ease of use and its value in the clinical setting.
Inclusion criteria: Adult; scheduled for surgery that requires peripheral nerve blockade
Exclusion criteria: Failure to provide informed consent; allergy to local anesthetic; neurological pathology and/or deficit in the block region.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-over-needle | Experimental | Procedure: Catheter-over-needlePatients will receive a catheter placed by a catheter-over-needle method. |
| Catheter-through-needle | Active comparator | Procedure: Catheter-through-needlePatients will receive a catheter placed by the traditional catheter-though-needle method. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (>18 yrs)
- Scheduled for surgery that requires continuous peripheral nerve block
Key exclusion criteria (3 listed)
- Failure to provide informed consent
- Allergy to local anesthetic
- Neurological pathology and/or deficit in the block region
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 |
|---|---|---|
| Catheter-over-needlePatients in the experimental group will receive a perineural catheter placed by the catheter-over-needle method. | Procedure or surgery | Catheter-over-needle |
| Catheter-through-needlePatients in the control group will receive a perineural catheter placed by the traditional catheter-though-needle method. | Procedure or surgery | Catheter-through-needle |
Primary outcome
Incidence of anesthetic/fluid leakage at catheter insertion site.
Time frame: Duration of time that perineural catheter is in the patient
Evidence of leakage of local anesthetic at the catheter insertion site and any catheter dislodgement or premature withdrawal will be recorded.
2 secondary outcomes
Confidence in accurate catheter placement.
Time frame: Duration of catheter placement in patient.
Time taken to place catheter near target nerve after initial skin puncture.
Time frame: From identification of needle insertion site to correct placement of needle in patient; approximately 2 minutes.
Results and safety
The study was stopped early (reason given: PI no longer at institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 24043379Ip VH, Rockley MC, Tsui BC. The catheter-over-needle assembly offers greater stability and less leakage compared with the traditional counterpart in continuous interscalene nerve blocks: a randomized patient-blinded study. Can J Anaesth. 2013 Dec;60(12):1272-3. doi: 10.1007/s12630-013-0032-6. Epub 2013 Sep 17. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter-over-needle and Catheter-through-needle in people with Local Anesthesia and Catheterization, run by University of Alberta 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 3 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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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 was stopped early (reason given: PI no longer at institution). Results are not available in the source record.
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?
Incidence of anesthetic/fluid leakage at catheter insertion site. (time frame: Duration of time that perineural catheter is in the patient). 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 NCT01522053, 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 25 Mar 2020.