Catheter-over-needle: Inpatient Study
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that the puncture hole left by the needle is larger than the diameter of the catheter, meaning that when the needle is withdrawn, the catheter is not secure, which increases the chance that it will dislodge and cause leakage of local anesthetic.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.
|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|
- Incidence of anesthetic/fluid leakage at catheter insertion site. [ Time Frame: Duration of time that perineural catheter is in the patient ] [ Designated as safety issue: No ]Evidence of leakage of local anesthetic at the catheter insertion site and any catheter dislodgement or premature withdrawal 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.
- 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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients will receive a catheter placed by a catheter-over-needle method.
Patients in the experimental group will receive a perineural catheter placed by the catheter-over-needle method.
Active Comparator: Catheter-through-needle
Patients will receive a catheter placed by the traditional catheter-though-needle method.
Patients in the control group will receive a perineural catheter placed by the traditional catheter-though-needle method.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522053
|Contact: Ban Tsui, MD, MScemail@example.com|
|University of Alberta Hospital||Recruiting|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator: Ban Tsui, MD, MSc|
|Sub-Investigator: Gareth Corry, PhD|