NCT03976154

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

6.3 years

First QC Date

June 3, 2019

Last Update Submit

March 4, 2025

Conditions

Thoracic Epidural

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (3)

  • Leakage

    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

    immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7

  • Opioid consumption

    daily up to 7 days post-operative

Study Arms (3)

Dermabond

EXPERIMENTAL

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

Mastisol

ACTIVE COMPARATOR

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

Grip-lock

ACTIVE COMPARATOR

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

Interventions

Thoracic Epidural Catheter Fixation TechniquesOTHER

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.

DermabondGrip-lockMastisol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgical patient
  • receiving a thoracic epidural
  • years of age or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

RECRUITING

Central Study Contacts

Ami Stuart, PhD

CONTACT

8017934800ami.stuart@hsc.utah.edu

Adam Meier, DO

CONTACT

8015876393adam.meier@hsc.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 5, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)