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Trial record 3 of 261561 for:    ALL

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

This study is not yet open for participant recruitment.
Verified December 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03375190
First Posted: December 15, 2017
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
December 5, 2017
December 15, 2017
December 15, 2017
February 2018
December 2018   (Final data collection date for primary outcome measure)
Force required to dislodge catheter by 1 centimeter [ Time Frame: 1 study day ]
This force will be measured using a dynamometer in Newtons
Same as current
No Changes Posted
Force required to disrupt catheter dressing [ Time Frame: 1 study day ]
This force will be measured using a dynamometer in Newtons
Same as current
Not Provided
Not Provided
 
A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Regional Anesthesia Morbidity
  • Other: Dressing
    Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
  • Other: Dressing + adhesive
    Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site
  • Other: Experimental: Dressing + adhesive + strips (parallel)
    Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter
  • Other: Experimental: Dressing + adhesive + strips (perpend)
    Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter
  • Other: Experimental: Dressing + adhesive + strips + benzoin
    Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site
  • Other: Experimental: Dressing + adhesive + strips + spray
    Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site
  • Experimental: Dressing
    Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
    Intervention: Other: Dressing
  • Experimental: Dressing + adhesive
    Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site
    Intervention: Other: Dressing + adhesive
  • Experimental: Dressing + adhesive + strips (parallel)
    Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter
    Intervention: Other: Experimental: Dressing + adhesive + strips (parallel)
  • Experimental: Dressing + adhesive + strips (perpend)
    Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter
    Intervention: Other: Experimental: Dressing + adhesive + strips (perpend)
  • Experimental: Dressing + adhesive + strips + benzoin
    Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site
    Intervention: Other: Experimental: Dressing + adhesive + strips + benzoin
  • Experimental: Dressing + adhesive + strips + spray
    Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site
    Intervention: Other: Experimental: Dressing + adhesive + strips + spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
6
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact: Amanda Kumar, MD 2163855529 amanda.kumar@duke.edu
Not Provided
 
 
NCT03375190
Pro00081185
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Duke University
Duke University
Not Provided
Principal Investigator: Michael Shaughnessy, MD Duke UMC
Duke University
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP