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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Regional Anesthesia Morbidity

Intervention / Treatment
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* Other: Dressing
* Other: Dressing + adhesive
* Other: Experimental: Dressing + adhesive + strips (parallel)
* Other: Experimental: Dressing + adhesive + strips (perpend)
* Other: Experimental: Dressing + adhesive + strips + benzoin
* Other: Experimental: Dressing + adhesive + strips + spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dressing<br>Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone | Other: Dressing<br>* Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone<br>|
| Experimental: Dressing + adhesive<br>Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site | Other: Dressing + adhesive<br>* Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site<br>|
| Experimental: Dressing + adhesive + strips (parallel)<br>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)<br>* 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<br>|
| Experimental: Dressing + adhesive + strips (perpend)<br>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)<br>* 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<br>|
| Experimental: Dressing + adhesive + strips + benzoin<br>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<br>* 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<br>|
| Experimental: Dressing + adhesive + strips + spray<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force required to dislodge catheter by 1 centimeter | This force will be measured using a dynamometer in Newtons | 1 study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force required to disrupt catheter dressing | This force will be measured using a dynamometer in Newtons | 1 study day |