Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

NCT ID: NCT03976154

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2025-12-31

Brief Summary

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The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok fixation bandage, two common, widely used techniques for epidural fixation.

Detailed Description

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Conditions

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Thoracic Epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dermabond

Catheter fixation will be performed after appropriate placement of a thoracic epidural with Dermabond. The investigator performing the thoracic epidural will distribute the Dermabond at the catheter insertion site in a space no greater than a 2 cm circle around the site. Once the Dermabond is allowed to dry, mastisol will be applied to the surrounding skin and a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia with a goal rate of 6ml/hr.

Group Type EXPERIMENTAL

Thoracic Epidural Catheter Fixation Techniques

Intervention Type OTHER

All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.

Epidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms.

Mastisol

Catheter fixation will be performed after appropriate placement of a thoracic epidural with Mastisol spray. The investigator performing the epidural placement will distribute Mastisol spray both in close proximity to the catheter insertion site as well as around the insertion site. Once the Mastisol is allowed to dry, a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team with a goal rate of 6ml/hr.

Group Type ACTIVE_COMPARATOR

Thoracic Epidural Catheter Fixation Techniques

Intervention Type OTHER

All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.

Epidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms.

Grip-lock

Catheter fixation will be performed after appropriate placement of a thoracic epidural with a Grip-Lok fixation bandage. The investigator performing the epidural placement will place the fixation bandage one centimeter caudal from the insertion site. Mastisol will be applied to the surrounding skin and a clear Tegaderm will then be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team in the operating room with a goal rate of 6ml/hr.

Group Type ACTIVE_COMPARATOR

Thoracic Epidural Catheter Fixation Techniques

Intervention Type OTHER

All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.

Epidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms.

Interventions

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Thoracic Epidural Catheter Fixation Techniques

All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.

Epidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* surgical patient
* receiving a thoracic epidural
* 18 years of age or older

Exclusion Criteria

* Patient refusal
* allergy to adhesives or local anesthesia
* pregnancy
* contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Adam Meier

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ami Stuart, PhD

Role: CONTACT

8017934800

Adam Meier, DO

Role: CONTACT

8015876393

Facility Contacts

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Julia L. White

Role: primary

801-587-4806

Other Identifiers

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122914

Identifier Type: -

Identifier Source: org_study_id

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