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Clinical Trials/NCT03375190
NCT03375190
Completed
Not Applicable

A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers

Duke University1 site in 1 country6 target enrollmentFebruary 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Regional Anesthesia Morbidity
Sponsor
Duke University
Enrollment
6
Locations
1
Primary Endpoint
Force required to dislodge catheter by 1 centimeter
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center, prospective study to compare peripheral nerve catheter securement techniques at the insertion site in healthy volunteers.

Detailed Description

This study will involve the placement of subcutaneous peripheral nerve catheters in healthy volunteers utilizing 6 different securement techniques. The primary outcome is the force required to dislodge the peripheral nerve catheter by 1 centimeter as measured by a dynamometer in Newtons. The secondary endpoint will be the force required to disrupt the catheter dressing.

Registry
clinicaltrials.gov
Start Date
February 15, 2018
End Date
February 28, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18-85 years
  • American Society of Anesthesiologists Physical Status I-II
  • BMI 18-30 kg/m2

Exclusion Criteria

  • Inability to cooperate with or understand protocol
  • Inability to understand or speak English
  • Allergy to adhesive or tape
  • Local infection in lower extremities
  • Neurologic deficit or disorder
  • Anticoagulation

Outcomes

Primary Outcomes

Force required to dislodge catheter by 1 centimeter

Time Frame: 1 study day

This force will be measured using a dynamometer in Newtons

Secondary Outcomes

  • Force required to disrupt catheter dressing(1 study day)

Study Sites (1)

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