Catheter-over-needle: Inpatient Study
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Purpose
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that the puncture hole left by the needle is larger than the diameter of the catheter, meaning that when the needle is withdrawn, the catheter is not secure, which increases the chance that it will dislodge and cause leakage of local anesthetic.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.
| Condition | Intervention |
|---|---|
|
Local Anesthesia Catheterization |
Procedure: Catheter placement method |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Comparison of the Catheter-over-needle and Catheter-through-needle Methods for Continuous Delivery of Local Anesthetic During Peripheral Nerve Blockade |
- 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. ] [ Designated as safety issue: No ]The time (in seconds) taken to correctly place the needle/catheter for delivery of local anesthetic will be recorded.
- Incidence of anesthetic/fluid leakage at catheter insertion site. [ Time Frame: During initial bolus delivery of local anesthetic; approximately 5 minutes. ] [ Designated as safety issue: No ]Evidence of leakage of local anesthetic from the catheter insertion site during bolus infusion will be recorded.
- Assessment of catheter stability at insertion site. [ Time Frame: Duration of catheter placement in patient ] [ Designated as safety issue: No ]Evidence of catheter movement/dislodgement during catheter placement and local anesthetic delivery will be recorded.
- Confidence in accurate catheter placement. [ Time Frame: Duration of catheter placement in patient. ] [ Designated as safety issue: No ]A subjective assessment of the catheterization and local anesthetic delivery technique will be provided by the anesthesiologist.
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Catheter-over-needle method
Patients will receive a catheter placed by a catheter-over-needle method.
|
Procedure: Catheter placement method
Patients in the experimental group will receive a perineural catheter placed by the catheter-over-needle method.
|
|
Active Comparator: Catheter-through-needle method
Patients will receive a catheter placed by the traditional catheter-though-needle method.
|
Procedure: Catheter placement method
Patients in the control group will receive a perineural catheter placed by the traditional catheter-though-needle method.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (>18 yrs)
- Scheduled for surgery that requires continuous peripheral nerve block
Exclusion Criteria:
- Failure to provide informed consent
- Allergy to local anesthetic
- Neurological pathology and/or deficit in the block region
Contacts and Locations| Contact: Ban Tsui, MD, MSc | 780-407-8604 | btsui@ualberta.ca |
| Canada, Alberta | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Principal Investigator: Ban Tsui, MD, MSc | |
| Sub-Investigator: Gareth Corry, PhD | |
More Information
No publications provided
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01522053 History of Changes |
| Other Study ID Numbers: | Pro000027409 |
| Study First Received: | January 26, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
ClinicalTrials.gov processed this record on May 21, 2013