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NCT Number: NCT03976154

Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

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.

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Key information

Conditions

Thoracic Epidural

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location status: Recruiting

Location contact

Harriet W. Hopf, MD

PRINCIPAL_INVESTIGATOR

Julia L. White

CONTACT

[email protected]

801-587-4806

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic Epidural Catheter Fixation Techniques

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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 outcomes

  1. 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

  2. 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

  3. Opioid consumption

    Time frame: daily up to 7 days post-operative

    Daily oral morphine equivalent totals

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Meier, DO

CONTACT

[email protected]

8015876393

Ami Stuart, PhD

CONTACT

[email protected]

8017934800

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2019
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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