Catheter-over-needle: Inpatient Study

NCT01522053 | Terminated

• 1 other identifier: Pro000027409
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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that the puncture hole left by the needle is larger than the diameter of the catheter, meaning that when the needle is withdrawn, the catheter is not secure, which increases the chance that it will dislodge and cause leakage of local anesthetic.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.

Conditions

Local Anesthesia; Catheterization

Outcome Measures

Primary Outcomes (1)

• 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.

  Duration of time that perineural catheter is in the patient

Secondary Outcomes (2)

• Confidence in accurate catheter placement.

  Duration of catheter placement in patient.

• Time taken to place catheter near target nerve after initial skin puncture.

  From identification of needle insertion site to correct placement of needle in patient; approximately 2 minutes.

Study Arms (2)

Catheter-over-needle

EXPERIMENTAL

Patients will receive a catheter placed by a catheter-over-needle method.

Procedure: Catheter-over-needle

Catheter-through-needle

ACTIVE COMPARATOR

Patients will receive a catheter placed by the traditional catheter-though-needle method.

Procedure: Catheter-through-needle

Interventions

Catheter-over-needle PROCEDURE

Patients in the experimental group will receive a perineural catheter placed by the catheter-over-needle method.

Catheter-over-needle

Catheter-through-needle PROCEDURE

Patients in the control group will receive a perineural catheter placed by the traditional catheter-though-needle method.

Catheter-through-needle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 yrs)
• Scheduled for surgery that requires continuous peripheral nerve block

You may not qualify if:

• Failure to provide informed consent
• Allergy to local anesthetic
• Neurological pathology and/or deficit in the block region

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• 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.

  PMID: 24043379 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

CA (1)