Labor PainNCT02984267
Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
A study testing Ultrasound and Palpation in people with Labor Pain, run by Thomas J. Vernon at 1 site in United States.
Trial summary
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Ultrasound and Palpation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 15 Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current (pregnant) BMI ≥ 40
- Age ≥ 18
- ASA score of 3 or less
- Full term pregnancy (37 weeks gestational age or greater)
Who cannot join
- Known scoliosis
- Known contraindications to neuraxial blockade
- Intrauterine fetal demise or non-viable fetus.
Trial locations and contacts
1 site in 1 country.
About this study
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.
- Conditions
- Labor Pain
- Being tested
- Ultrasound, Palpation
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Using ultrasound guidance to evaluate the spine prior to epidural placement
PalpationOther
Using palpation only to evaluate the spine prior to epidural placement
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Group | Experimental | The interventional group that will have their spine evaluated by ultrasound prior to epidural placement Receives: Device: Ultrasound |
| Palpation Group | Other | The control group that will have their epidural placed in the usual fashion based on palpation Receives: Other: Palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Time Required for Epidural Catheter Placement
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
Measured: Assessed immediately during epidural catheter placement
Secondary outcomes (9)
Epidural Procedure Time
Time required to successfully place the epidural catheter
Measured: Assessed immediately during epidural catheter placement
Number of Attempts at Epidural Catheter Placement
Measured: Assessed immediately during epidural catheter placement
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Measured: Assessed immediately during epidural catheter placement
Complications
Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.
Measured: Assessed immediately during epidural catheter placement and within 24 hours after delivery
Epidural Failure Rate
Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported
Measured: Assessed within 24 hours after delivery
Epidural Catheter Placement Satisfaction Level
Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.
Measured: Assessed immediately following epidural catheter placement
Patient Anxiety Level
Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.
Measured: Assessed immediately following epidural catheter placement
Palpation or Ultrasound Time
The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion
Measured: Assessed immediately prior to epidural catheter placement
Overall Anesthesia Experience Satisfaction
Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.
Measured: Measured within 24 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
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 Labor PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas J. Vernon
- Sponsor type
- University, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Responsible party
- Sponsor-investigator, Thomas J. Vernon, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984267
- Sponsor's protocol ID
- OBUS1123
- Status last verified
- Jun 2018
- First submitted
- 23 Nov 2016
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound Guidance to Assist With Labor Epidural Placement in Patients With a BMI ≥40
- ClinicalTrials.gov ID
- NCT02984267
- Acronym / sponsor ID
- OBUS1123
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Thomas J. VernonUniversity, hospital or other
- Collaborators
- West Penn Allegheny Health System
- Study start
- Dec 2016
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Placement of labor epidurals is a very common daily practice in obstetrical anesthesia. Currently, these epidurals are placed based upon palpation of landmarks to determine midline and the correct spinal level for placement. Palpation of these landmarks can be difficult, however, particularly in morbidly obese patients who have significant amounts of soft tissue overlying them. This study seeks to use ultrasound guidance to examine the spine prior to epidural placement, and see what effects this has compared to palpation alone with respect to procedure time, number of attempts, success rate in the first attempt, failure rate, complication rate, patient anxiety levels, and patient satisfaction levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Group | Experimental | Device: UltrasoundThe interventional group that will have their spine evaluated by ultrasound prior to epidural placement |
| Palpation Group | Other | Other: PalpationThe control group that will have their epidural placed in the usual fashion based on palpation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current (pregnant) BMI ≥ 40
- Age ≥ 18
- ASA score of 3 or less
- Full term pregnancy (37 weeks gestational age or greater)
Key exclusion criteria (3 listed)
- Known scoliosis
- Known contraindications to neuraxial blockade
- Intrauterine fetal demise or non-viable fetus.
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 |
|---|---|---|
| UltrasoundUsing ultrasound guidance to evaluate the spine prior to epidural placement | Device | Ultrasound Group |
| PalpationUsing palpation only to evaluate the spine prior to epidural placement | Other | Palpation Group |
Primary outcome
Total Time Required for Epidural Catheter Placement
Time frame: Assessed immediately during epidural catheter placement
Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter
9 secondary outcomes
Epidural Procedure Time
Time frame: Assessed immediately during epidural catheter placement
Number of Attempts at Epidural Catheter Placement
Time frame: Assessed immediately during epidural catheter placement
Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt
Time frame: Assessed immediately during epidural catheter placement
Complications
Time frame: Assessed immediately during epidural catheter placement and within 24 hours after delivery
Epidural Failure Rate
Time frame: Assessed within 24 hours after delivery
Epidural Catheter Placement Satisfaction Level
Time frame: Assessed immediately following epidural catheter placement
Patient Anxiety Level
Time frame: Assessed immediately following epidural catheter placement
Palpation or Ultrasound Time
Time frame: Assessed immediately prior to epidural catheter placement
Overall Anesthesia Experience Satisfaction
Time frame: Measured within 24 hours of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Ultrasound and Palpation in people with Labor Pain, run by Thomas J. Vernon 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 4 inclusion and 3 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 11 Jul 2018. 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 11 Jul 2018). 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?
Total Time Required for Epidural Catheter Placement (time frame: Assessed immediately during epidural catheter placement). 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 11 Jul 2018.