Effects of Fixation Technique on Thoracic Epidural Catheter Displacement

The Effects of Fixation Technique on Thoracic Epidural Catheter Displacement: a Single-Center Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Epidural
• Intervention / Treatment: Other: Thoracic Epidural Catheter Fixation Techniques

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Meier, DO; Phone Number: 8015876393; Email: adam.meier@hsc.utah.edu
• Study Contact Backup: Name: Ami Stuart, PhD; Phone Number: 8017934800; Email: ami.stuart@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Health Sciences Center
      • Contact: Julia L. White; Phone Number: 801-587-4806; Email: julia.white@hsc.utah.edu
      • Contact: Harriet W. Hopf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidural catheter displacement immediately after surgery	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	immediately after surgery in PACU
Epidural catheter displacement day 1	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	24 hours post-operative
Epidural catheter displacement day 2	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	48 hours post-operative
Epidural catheter displacement day 3	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	72 hours post-operative
Epidural catheter displacement day 4	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	96 hours post-operative
Epidural catheter displacement day 5	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	120 hours post-operative
Epidural catheter displacement day 6	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	144 hours post-operative
Epidural catheter displacement day 7	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm	168 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leakage	presence of any leakage from catheter fixation	immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7
Percent of patients with skin changes as measured by clinician subjective assessment	The clinician will subjectively assess any skin changes including induration or erythema	immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7
Opioid consumption	Daily oral morphine equivalent totals	daily up to 7 days post-operative

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: 122914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No