Recruiting NCT03976154
Effects of Fixation Technique On Thoracic Epidural Catheter Displacement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoracic Epidural Catheter Fixation Techniques.
- Who it may be relevant to
- Registry conditions: Thoracic Epidural. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Fixation Technique On Thoracic Epidural Catheter Displacement: A Single-Center Randomized Controlled Trial
Overview
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
- 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,
Primary outcome measures
- Epidural catheter displacement immediately after surgery [Time frame: immediately after surgery in PACU]
- Epidural catheter displacement day 1 [Time frame: 24 hours post-operative]
- Epidural catheter displacement day 2 [Time frame: 48 hours post-operative]
- Epidural catheter displacement day 3 [Time frame: 72 hours post-operative]
- Epidural catheter displacement day 4 [Time frame: 96 hours post-operative]
- Epidural catheter displacement day 5 [Time frame: 120 hours post-operative]
- Epidural catheter displacement day 6 [Time frame: 144 hours post-operative]
- Epidural catheter displacement day 7 [Time frame: 168 hours post-operative]
Secondary outcome measures (3)
- Leakage [Time frame: 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 [Time frame: immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7]
- Opioid consumption [Time frame: daily up to 7 days post-operative]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Utah Health Sciences Center — Salt Lake City
Identifiers
NCT: NCT03976154 · 122914