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

Regional Anesthesia Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375190
• Other study ID #: Pro00081185
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Other:
• Dressing
Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
• Dressing + adhesive
Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force required to dislodge catheter by 1 centimeter	This force will be measured using a dynamometer in Newtons	1 study day
Secondary	Force required to disrupt catheter dressing	This force will be measured using a dynamometer in Newtons	1 study day