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

Not Applicable

Completed

• Conditions: Regional Anesthesia Morbidity
• Interventions: Other: Dressing; Other: Dressing + adhesive

• Registration Number: NCT03375190
• Lead Sponsor: Duke University

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.

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.

Study Timeline

• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-15
• Study Start: 2018-02-15
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Force required to dislodge catheter by 1 centimeter	1 study day	This force will be measured using a dynamometer in Newtons

Secondary Outcome Measures

Name	Time	Method
Force required to disrupt catheter dressing	1 study day	This force will be measured using a dynamometer in Newtons

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States