Catheter-over-needle: Inpatient Study
|ClinicalTrials.gov Identifier: NCT01522053|
Recruitment Status : Unknown
Verified December 2014 by University of Alberta.
Recruitment status was: Active, not recruiting
First Posted : January 31, 2012
Last Update Posted : December 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Local Anesthesia Catheterization||Procedure: Catheter-over-needle Procedure: Catheter-through-needle||Not Applicable|
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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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||July 2016|
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.
- 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.
- Confidence in accurate catheter placement. [ Time Frame: Duration of catheter placement in patient. ]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. ]The time (in seconds) taken to correctly place the needle/catheter for delivery of local anesthetic will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522053
|University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2B7|