A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedStudy Start
First participant enrolled
February 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedMay 14, 2018
May 1, 2018
13 days
December 5, 2017
May 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Force required to dislodge catheter by 1 centimeter
This force will be measured using a dynamometer in Newtons
1 study day
Secondary Outcomes (1)
Force required to disrupt catheter dressing
1 study day
Study Arms (6)
Dressing
EXPERIMENTALTransparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
Dressing + adhesive
EXPERIMENTALTransparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site
Dressing + adhesive + strips (parallel)
EXPERIMENTALTransparent 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
Dressing + adhesive + strips (perpend)
EXPERIMENTALTransparent 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
Dressing + adhesive + strips + benzoin
EXPERIMENTALTransparent 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
Dressing + adhesive + strips + spray
EXPERIMENTALTransparent 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
Interventions
Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site
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
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
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
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
Eligibility Criteria
You may qualify if:
- Age 18-85 years
- American Society of Anesthesiologists Physical Status I-II
- BMI 18-30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
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.
PMID: 33406276DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Shaughnessy, MD
Duke UMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2017
First Posted
December 15, 2017
Study Start
February 15, 2018
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
May 14, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share