Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

Thoracic Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976154
• Other study ID #: 122914
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: August 30, 2024

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: Ami Stuart, PhD
• Phone: 8017934800
• Email: ami.stuart[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Epidural

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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