Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

Not Applicable

Recruiting

• Conditions: Thoracic Epidural
• Interventions: Other: Thoracic Epidural Catheter Fixation Techniques

• 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: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

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

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grip-lock	Thoracic Epidural Catheter Fixation Techniques	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.
Mastisol	Thoracic Epidural Catheter Fixation Techniques	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.
Dermabond	Thoracic Epidural Catheter Fixation Techniques	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.

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