CClinicalTrials.gg
CompletedNCT03375190Updated May 14, 2018

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

An interventional study of Dressing and Dressing + adhesive in Regional Anesthesia Morbidity, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by Duke University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Regional Anesthesia Morbidity
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Dressing

    Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone

    Other: Dressing

  • Experimental
    Dressing + adhesive

    Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site

    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

    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

    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

    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

    Other: Experimental: Dressing + adhesive + strips + spray

Interventions

  • OtherDressing

    Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone

  • OtherDressing + adhesive

    Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site

  • OtherExperimental: 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

  • OtherExperimental: 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

  • OtherExperimental: 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

  • OtherExperimental: 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

05

What researchers measure

Primary outcomes

  1. Force required to dislodge catheter by 1 centimeter

    This force will be measured using a dynamometer in Newtons

    Time frame: 1 study day

Secondary outcomes

  1. Force required to disrupt catheter dressing

    This force will be measured using a dynamometer in Newtons

    Time frame: 1 study day

06

Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
07

References and documents

Publications

  • Kumar AH, MacLeod DB, Kumar KR, Ray N, Gadsden J. Comparison of perineural catheter fixation methods: a volunteer study. Anaesthesia. 2021 May;76(5):714-716. doi: 10.1111/anae.15372. Epub 2021 Jan 6. No abstract available. PubMed 33406276 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03375190
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Dec 15, 2017
Start date
Feb 15, 2018
Primary completion
Feb 28, 2018
Completion
Feb 28, 2018
Last update
May 14, 2018

Study contacts

Michael Shaughnessy, MD
principal investigator · Duke UMC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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