Effects of Fixation Technique On Thoracic Epidural Catheter Displacement

Study Overview
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Brief Summary
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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.

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

Conditions
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Thoracic Epidural

Intervention / Treatment
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* Other: Thoracic Epidural Catheter Fixation Techniques


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermabond<br>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<br>* 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.<br>|
| Active Comparator: Mastisol<br>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<br>* 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.<br>|
| Active Comparator: Grip-lock<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Opioid consumption | Daily oral morphine equivalent totals | daily up to 7 days post-operative |