Effects of Fixation Technique on Thoracic Epidural Catheter Displacement

Not Applicable

Recruiting

• Conditions: Thoracic Epidural

• Registration Number: NCT03976154
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-05
• Study Start: 2019-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Epidural catheter displacement day 1	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	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 immediately after surgery	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 4	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 3	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 5	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 7	168 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	144 hours post-operative	Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm

Secondary Outcome Measures

Name	Time	Method
Leakage	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	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	daily up to 7 days post-operative	Daily oral morphine equivalent totals

Trial Locations

Locations (1)

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States