Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

Overview

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.

Full Title of Study: “The Effects of Fixation Technique On Thoracic Epidural Catheter Displacement: A Single-Center Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 30, 2024

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Utah
  • Provider of Information About this Clinical Study
    • Principal Investigator: Adam Meier, Associate Professor – University of Utah
  • Overall Contact(s)
    • Ami Stuart, PhD, 8017934800, ami.stuart@hsc.utah.edu

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