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Epidural Catheter Fixation Techniques for Thoracic Epidural Management

N/A

Recruiting

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical patient receiving a thoracic epidural

18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after surgery in pacu

Awards & highlights

Study Summary

This trialcompares three techniques to secure epidurals: Dermabond, Mastisol and Grip-Lok. Results will help determine which is most effective.

Who is the study for?

This trial is for surgical patients aged 18 or older who are scheduled to receive a thoracic epidural. It's not suitable for pregnant individuals, those who refuse to participate, have allergies to adhesives/local anesthesia, or conditions that make getting an epidural unsafe like bleeding disorders, infections, high brain pressure, or severe neurological issues.Check my eligibility

What is being tested?

The study is comparing three ways of securing a thoracic epidural catheter: using Dermabond (a medical glue), Mastisol (an adhesive liquid), and the Grip-Lok fixation bandage. The goal is to see which method keeps the catheter in place most effectively during surgery.See study design

What are the potential side effects?

Potential side effects may include skin irritation at the site where the catheter is secured due to reactions with adhesives used in Dermabond and Mastisol or from wearing the Grip-Lok bandage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery with a thoracic epidural for pain relief.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 168 hours post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~168 hours post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 hours post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Epidural catheter displacement day 1

Epidural catheter displacement day 2

Epidural catheter displacement day 3

+5 more

Secondary outcome measures

Leakage

Opioid consumption

Percent of patients with skin changes as measured by clinician subjective assessment

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: DermabondExperimental Treatment1 Intervention

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 II: MastisolActive Control1 Intervention

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 III: Grip-lockActive Control1 Intervention

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,099 Previous Clinical Trials

1,778,389 Total Patients Enrolled

Media Library

Dermabond Clinical Trial Eligibility Overview. Trial Name: NCT03976154 — N/A

Thoracic Epidural Research Study Groups: Dermabond, Mastisol, Grip-lock

Thoracic Epidural Clinical Trial 2023: Dermabond Highlights & Side Effects. Trial Name: NCT03976154 — N/A

Dermabond 2023 Treatment Timeline for Medical Study. Trial Name: NCT03976154 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the patient cohort for this clinical trial?

"Affirmative. According to clinicaltrials.gov, the recruitment for this trial is currently in progress, having initially gone live on October 1st 2019. The most recent update was made on November 2nd 2022 and 300 patients are being sought from a single medical site."

Answered by AI

Is there still an opportunity to volunteer for this experiment?

"According to clinicaltrials.gov, this study is currently enrolling patients and has been active since October 1st 2019 with its most recent edit occurring on November 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

Adam Meier 2019. "Effects of Fixation Technique On Thoracic Epidural Catheter Displacement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03976154.