Thoracic Epidural
Conditions
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.
Interventions
OTHERThoracic 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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 6 | 144 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 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 day 3 | 72 hours post-operative | Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactAmi Stuart, PhD
Backup ContactAdam Meier, DO
Outcome results
None listed