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

Duke University logo

Duke University

Status

Completed

Conditions

Regional Anesthesia Morbidity

Treatments

Other: Experimental: Dressing + adhesive + strips + spray
Other: Experimental: Dressing + adhesive + strips + benzoin
Other: Experimental: Dressing + adhesive + strips (perpend)
Other: Dressing
Other: Experimental: Dressing + adhesive + strips (parallel)
Other: Dressing + adhesive

Study type

Interventional

Funder types

Other

Identifiers

NCT03375190
Pro00081185

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

6 participants in 6 patient groups

Dressing
Experimental group
Description:
Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
Treatment:
Other: Dressing
Dressing + adhesive
Experimental group
Description:
Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site
Treatment:
Other: Dressing + adhesive
Dressing + adhesive + strips (parallel)
Experimental group
Description:
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
Treatment:
Other: Experimental: Dressing + adhesive + strips (parallel)
Dressing + adhesive + strips (perpend)
Experimental group
Description:
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
Treatment:
Other: Experimental: Dressing + adhesive + strips (perpend)
Dressing + adhesive + strips + benzoin
Experimental group
Description:
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
Treatment:
Other: Experimental: Dressing + adhesive + strips + benzoin
Dressing + adhesive + strips + spray
Experimental group
Description:
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
Treatment:
Other: Experimental: Dressing + adhesive + strips + spray

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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