Thoracic EpiduralNCT03976154
Effects of Fixation Technique On Thoracic Epidural Catheter Displacement
A study testing Thoracic Epidural Catheter Fixation Techniques in people with Thoracic Epidural, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Epidural
- What is being tested?
- Thoracic Epidural Catheter Fixation Techniques
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical patient
- receiving a thoracic epidural
- 18 years of age or older
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
Julia L. White, 801-587-4806, julia.white@hsc.utah.edu
Harriet W. Hopf, MD
About this study
Official title: The Effects of Fixation Technique On Thoracic Epidural Catheter Displacement: A Single-Center Randomized Controlled 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.
- Conditions
- Thoracic Epidural
- Being tested
- Thoracic Epidural Catheter Fixation Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Epidural Catheter Fixation TechniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dermabond | Experimental | 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. Receives: Other: Thoracic Epidural Catheter Fixation Techniques |
| Mastisol | Active comparator | 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. Receives: Other: Thoracic Epidural Catheter Fixation Techniques |
| Grip-lock | Active comparator | 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. Receives: Other: Thoracic Epidural Catheter Fixation Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural catheter displacement immediately after surgery
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 168 hours post-operative
Secondary outcomes (3)
Leakage
presence of any leakage from catheter fixation
Measured: 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
Measured: 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
Measured: daily up to 7 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic EpiduralStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Meier, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976154
- Sponsor's protocol ID
- 122914
- Status last verified
- Mar 2025
- First submitted
- 3 Jun 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fixation Technique On Thoracic Epidural Catheter Displacement: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03976154
- Acronym / sponsor ID
- 122914
- Conditions
- Thoracic Epidural
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dermabond | Experimental | Other: Thoracic Epidural Catheter Fixation TechniquesCatheter 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. |
| Mastisol | Active comparator | Other: Thoracic Epidural Catheter Fixation TechniquesCatheter 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. |
| Grip-lock | Active comparator | Other: Thoracic Epidural Catheter Fixation TechniquesCatheter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgical patient
- receiving a thoracic epidural
- 18 years of age or older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Epidural Catheter Fixation TechniquesAll 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. | Other | Dermabond, Grip-lock, Mastisol |
Primary outcome
Epidural catheter displacement immediately after surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 4
Time frame: 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
Time frame: 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
Time frame: 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 day 7
Time frame: 168 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Epidural Catheter Fixation Techniques in people with Thoracic Epidural, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ami Stuart, PhD (8017934800, ami.stuart@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural catheter displacement immediately after surgery (time frame: immediately after surgery in PACU). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.