Effects of Fixation Technique On Thoracic Epidural Catheter Displacement
ConditionThoracic Epidural
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
surgical patient
receiving a thoracic epidural
18 years of age or older
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Thoracic Epidural Catheter Fixation Techniques
Other interventionAll 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: DermabondExperimental treatment 1 intervention
Group B: MastisolActive comparator 1 intervention
Group C: Grip-lockActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Epidural catheter displacement immediately after surgery
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Time frame
immediately after surgery in PACU2
Epidural catheter displacement day 1
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Time frame
24 hours post-operative3
Epidural catheter displacement day 2
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Time frame
48 hours post-operative4
Epidural catheter displacement day 3
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Time frame
72 hours post-operativeSecondary outcomes
1
Leakage
presence of any leakage from catheter fixation
Time frame
immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 72
Percent of patients with skin changes as measured by clinician subjective assessment
The clinician will subjectively assess any skin changes including induration or erythema
Time frame
immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 73
Opioid consumption
Daily oral morphine equivalent totals
Time frame
daily up to 7 days post-operativeSponsors and contacts
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Source ClinicalTrials.gov