Analgesia, ObstetricalNCT03574441
Intrapartum Epidural Catheter Displacement: Dressing Methods
A study testing Tegaderm dressing + catheter support pad, Tegaderm dressing + Steri-strip dressing and Tegaderm dressing only in people with Analgesia, Obstetrical, run by Augusta University at 1 site in United States.
Trial summary
Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Obstetrical
- What is being tested?
- Tegaderm dressing + catheter support pad, Tegaderm dressing + Steri-strip dressing and Tegaderm dressing only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2017to 18 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia.
- BMI >30 kg/m2.
- Age older than 18 years old.
Who cannot join
- Allergy to adhesive tape or to the components of the dressings used in the study.
- Preexisting sensory neurologic deficits affecting lower extremities.
- Patients taken to the operating room for cesarean section during the study period.
- Chronic pain conditions.
- Patients with intrathecal catheters.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. It has been argued that prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed epidurals in obstetrics.
Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.
Read the detailed description
Primary aim: The investigators will evaluate the efficacy of three different epidural catheter dressing systems in laboring patients.
Secondary aims: To compare the effect of different degrees of obesity measured by BMI, on epidural catheter migration and quality and failure of epidural labor analgesia. To evaluate the effect of time an indwelling catheter remains in place, level of insertion and patient's height on epidural catheter migration.
Hypothesis: The use of dressing with transparent TegadermTM plus catheter support pad dressing is superior to the dressing with TegadermTM plus Steri-StripTM bands, and to a dressing with TegadermTM only, for epidural catheter fixation in laboring obese and morbidly obese patients, in terms of catheter migration. epidural quality and failure and epidural catheter replacement in the labor analgesia setting.
- Conditions
- Analgesia, Obstetrical
- Being tested
- Tegaderm dressing + catheter support pad, Tegaderm dressing + Steri-strip dressing, Tegaderm dressing only
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaderm dressing + catheter support padDevice
Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
Tegaderm dressing + Steri-strip dressingDevice
Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
Tegaderm dressing onlyDevice
Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
| Study group | Role | What they receive |
|---|---|---|
| TegadermTM only | Active comparator | Not described Receives: Device: Tegaderm dressing only |
| Dressing with TegadermTM plus Steri-StripTM bands | Active comparator | Not described Receives: Device: Tegaderm dressing + Steri-strip dressing |
| Dressing with TegadermTM plus catheter support pad. | Experimental | Not described Receives: Device: Tegaderm dressing + catheter support pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural Catheter Migration
Percentage of participants for whom catheter migration was observed
Measured: 24 hours. The time from insertion to removal of catheter
Secondary outcomes (1)
Rate of Epidural Catheter Replacement
Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm
Measured: 24 hours. The time from insertion to removal of catheter due to failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start4 Dec 2017
- Primary completion11 Mar 2018
- Study completion18 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Analgesia, ObstetricalStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized using a random number table to be allocated to one of three groups with sealed envelopes, based on the type of dressing to be used to secure the epidural catheter after its insertion: 1. TegadermTM plus catheter support pad. 2. Dressing with TegadermTM plus Steri-StripTM bands 3. Dressing with TegadermTM only
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574441
- Sponsor's protocol ID
- 1048027
- Status last verified
- Jul 2019
- First submitted
- 1 Jun 2018
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Epidural Catheter Displacement: Comparison of Three Dressing Methods in Morbidly Obese Parturients
- ClinicalTrials.gov ID
- NCT03574441
- Acronym / sponsor ID
- 1048027
- Conditions
- Analgesia, Obstetrical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 11 Mar 2018 (actual)
- Study completion
- 18 Mar 2018 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Failure of labor epidural is a well-recognized situation in obstetric anesthesia practice. Incidence of epidural failure was shown to be 12% in a retrospective analysis of 19,259 deliveries. Epidural migration has been documented in both the obstetric and non-obstetric settings. It has been argued that prevention of epidural displacement is a potential remedy to at least part of the incomplete or failed epidurals in obstetrics.
Purpose: The investigators propose this study to prospectively evaluate the efficacy of the three types of epidural catheter dressings that are currently in use in clinical practice, in terms of catheter migration, taking into consideration the influence of body mass index on this variable.
Detailed description
Primary aim: The investigators will evaluate the efficacy of three different epidural catheter dressing systems in laboring patients.
Secondary aims: To compare the effect of different degrees of obesity measured by BMI, on epidural catheter migration and quality and failure of epidural labor analgesia. To evaluate the effect of time an indwelling catheter remains in place, level of insertion and patient's height on epidural catheter migration.
Hypothesis: The use of dressing with transparent TegadermTM plus catheter support pad dressing is superior to the dressing with TegadermTM plus Steri-StripTM bands, and to a dressing with TegadermTM only, for epidural catheter fixation in laboring obese and morbidly obese patients, in terms of catheter migration. epidural quality and failure and epidural catheter replacement in the labor analgesia setting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients were randomized using a random number table to be allocated to one of three groups with sealed envelopes, based on the type of dressing to be used to secure the epidural catheter after its insertion: 1. TegadermTM plus catheter support pad. 2. Dressing with TegadermTM plus Steri-StripTM bands 3. Dressing with TegadermTM only
| Arm | Type | Receives |
|---|---|---|
| TegadermTM only | Active comparator | Device: Tegaderm dressing only |
| Dressing with TegadermTM plus Steri-StripTM bands | Active comparator | Device: Tegaderm dressing + Steri-strip dressing |
| Dressing with TegadermTM plus catheter support pad. | Experimental | Device: Tegaderm dressing + catheter support pad |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the Labor and delivery Unit at Augusta University Medical Center who request epidural analgesia.
- BMI >30 kg/m2.
- Age older than 18 years old.
Key exclusion criteria (5 listed)
- Allergy to adhesive tape or to the components of the dressings used in the study.
- Preexisting sensory neurologic deficits affecting lower extremities.
- Patients taken to the operating room for cesarean section during the study period.
- Chronic pain conditions.
- Patients with intrathecal catheters.
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 |
|---|---|---|
| Tegaderm dressing + catheter support padTegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter | Device | Dressing with TegadermTM plus catheter support pad. |
| Tegaderm dressing + Steri-strip dressingTegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter | Device | Dressing with TegadermTM plus Steri-StripTM bands |
| Tegaderm dressing onlyTegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter | Device | TegadermTM only |
Primary outcome
Epidural Catheter Migration
Time frame: 24 hours. The time from insertion to removal of catheter
Percentage of participants for whom catheter migration was observed
1 secondary outcome
Rate of Epidural Catheter Replacement
Time frame: 24 hours. The time from insertion to removal of catheter due to failure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegaderm dressing + catheter support pad, Tegaderm dressing + Steri-strip dressing and Tegaderm dressing only in people with Analgesia, Obstetrical, run by Augusta University 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 5 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: finished, as of the sponsor's last update on 30 Jul 2019. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural Catheter Migration (time frame: 24 hours. The time from insertion to removal of catheter). 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 30 Jul 2019.