Labor PainNCT04020042
Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
A study testing Ultrasound image guidance and Landmark palpation in people with Labor Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to complete labor epidural placement and success rate of epidural analgesia in parturients with a wide range of body mass indexes (BMIs). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Ultrasound image guidance and Landmark palpation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2019to 23 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years
- Parturient in active labor and desires labor epidural for pain relief.
- American Society of Anesthesiologists (ASA) Class I, 2 and 3 parturients, which include normal parturients
- Parturients with morbidities (including obesity) that are not life-threatening,
- Parturient BMI ≥ 25
Who cannot join
- History of scoliosis or back surgery
- Patient refusal
- Patient with elevated intracranial pressure
- Any patient with a contraindication for placement of epidural anesthesia, including infection at needle insertion site, or coagulopathy.
- ASA Class 4
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health Hospital System
Dallas, Texas, 75390
About this study
Official title: Timely Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation in Parturients With Various Body Mass Indices (BMI): A Prospective Randomized Clinical Trial
Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to complete labor epidural placement and success rate of epidural analgesia in parturients with a wide range of body mass indexes (BMIs).
A handheld ultrasound device (Accuro, Rhivanna Medical, Charlottesville, VA) may eliminate the time for equipment setup due to its portability and instant power-up. In addition, it provides a simulated diagram to aid in identifying bone and lumbar spaces. These unique features may be helpful in laboring women with a particular BMI range. We aim to define the usefulness of guidance with a handheld ultrasound in completing labor epidural analgesia in various BMIs.
Read more
The primary outcome: The time needed to complete epidural placements.
Secondary outcomes:
- The number of needle insertion attempts,
- The rate of success measured by the need to replacements during the labor course for vaginal or cesarean delivery.
Read the detailed description
This randomized prospective clinical trial aims to evaluate timing savings in performing labor epidural analgesia and the success rate of labor analgesia with and without the guidance of a handheld ultrasound device in various BMI groups.
In routine clinical setting, patients admitted to clinic and evaluated labor condition. If patient in active labor and request epidural for labor pain, the standard care team inform obstetric anesthesia epidural team by using pager. Standard of care anesthesia epidural team perform preoperative evaluation and placed the catheter.
The patients in active labor will receive labor epidural analgesia, regardless of the study participation. There is no changes epidural local anesthetic type and doses. The research intervention is only placing hand-hold ultrasound to the back of the patient and see the land mark visually before the epidural catheter placement. The remaining catheter placement is the same as the control group.
Study Procedures:
A Total of 300 eligible parturients will be randomly assigned to one of the two groups either the ultrasound imaging guidance or the traditional landmark palpation group for labor epidural needle placement. The research intervention is simply placing a hand-held ultrasound device on the back of the patient and insert the epidural needle with ultrasound image guidance.
Parturient will receive epidural catheter regardless of the study participation. In the traditional landmark method, anesthetist palpates the structure to determine the site of the initial needle insertion site. The needle will be protruded as in usual standard practice. Anesthetist may remove and insert needle again until feeling epidural space. When anesthetist determine the tip of the needle is in the epidural space, the epidural catheter will be protruded through the needle.
- Conditions
- Labor Pain
- Being tested
- Ultrasound image guidance, Landmark 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.
Ultrasound image guidanceOther
Epidural landmarks will be determined with using ultrasound image
Landmark palpationOther
Also called Determination of epidural lanmakrks with palpation
Epidural landmarks will be determined with palpation
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound imaging guidance | Experimental | Determination of epidural needle site by using ultrasound guidance Receives: Other: Ultrasound image guidance |
| Traditional landmark palpation | Active comparator | Depermination of epidural needle site by using traditional landmark method Receives: Other: Landmark palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time needed to complete epidural placements
The number of removal and insertion of the epidural needle until feeling epidural space.
Measured: Within 10 minutes during epidural needle placement
Secondary outcomes (1)
The number of needle insertion attempts
The epidural needle insertion attempts
Measured: Within 10 minutes during epidural needle placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start28 Aug 2019
- Primary completion23 Mar 2021
- Study completion23 Mar 2021
Why it stopped: Manpower issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weike Tao, University of Texas Southwestern Medical Center
- Investigators
- Seema Dave, MPH, Study director, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020042
- Sponsor's protocol ID
- STU-2019-0571
- Status last verified
- May 2022
- First submitted
- 12 Jul 2019
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation in Parturients With Various Body Mass Indices (BMI): A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04020042
- Acronym / sponsor ID
- STU-2019-0571
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manpower issues
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 23 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 15 Jul 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.
Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to complete labor epidural placement and success rate of epidural analgesia in parturients with a wide range of body mass indexes (BMIs).
A handheld ultrasound device (Accuro, Rhivanna Medical, Charlottesville, VA) may eliminate the time for equipment setup due to its portability and instant power-up. In addition, it provides a simulated diagram to aid in identifying bone and lumbar spaces. These unique features may be helpful in laboring women with a particular BMI range. We aim to define the usefulness of guidance with a handheld ultrasound in completing labor epidural analgesia in various BMIs.
The primary outcome: The time needed to complete epidural placements.
Secondary outcomes:
- The number of needle insertion attempts,
- The rate of success measured by the need to replacements during the labor course for vaginal or cesarean delivery.
Detailed description
This randomized prospective clinical trial aims to evaluate timing savings in performing labor epidural analgesia and the success rate of labor analgesia with and without the guidance of a handheld ultrasound device in various BMI groups.
In routine clinical setting, patients admitted to clinic and evaluated labor condition. If patient in active labor and request epidural for labor pain, the standard care team inform obstetric anesthesia epidural team by using pager. Standard of care anesthesia epidural team perform preoperative evaluation and placed the catheter.
The patients in active labor will receive labor epidural analgesia, regardless of the study participation. There is no changes epidural local anesthetic type and doses. The research intervention is only placing hand-hold ultrasound to the back of the patient and see the land mark visually before the epidural catheter placement. The remaining catheter placement is the same as the control group.
Study Procedures:
A Total of 300 eligible parturients will be randomly assigned to one of the two groups either the ultrasound imaging guidance or the traditional landmark palpation group for labor epidural needle placement. The research intervention is simply placing a hand-held ultrasound device on the back of the patient and insert the epidural needle with ultrasound image guidance.
Parturient will receive epidural catheter regardless of the study participation. In the traditional landmark method, anesthetist palpates the structure to determine the site of the initial needle insertion site. The needle will be protruded as in usual standard practice. Anesthetist may remove and insert needle again until feeling epidural space. When anesthetist determine the tip of the needle is in the epidural space, the epidural catheter will be protruded through the needle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound imaging guidance | Experimental | Other: Ultrasound image guidanceDetermination of epidural needle site by using ultrasound guidance |
| Traditional landmark palpation | Active comparator | Other: Landmark palpationDepermination of epidural needle site by using traditional landmark method |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-50 years
- Parturient in active labor and desires labor epidural for pain relief.
- American Society of Anesthesiologists (ASA) Class I, 2 and 3 parturients, which include normal parturients
- Parturients with morbidities (including obesity) that are not life-threatening,
- Parturient BMI ≥ 25
Key exclusion criteria (5 listed)
- History of scoliosis or back surgery
- Patient refusal
- Patient with elevated intracranial pressure
- Any patient with a contraindication for placement of epidural anesthesia, including infection at needle insertion site, or coagulopathy.
- ASA Class 4
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 |
|---|---|---|
| Ultrasound image guidanceEpidural landmarks will be determined with using ultrasound image | Other | Ultrasound imaging guidance |
| Landmark palpationAlso: Determination of epidural lanmakrks with palpationEpidural landmarks will be determined with palpation | Other | Traditional landmark palpation |
Primary outcome
The time needed to complete epidural placements
Time frame: Within 10 minutes during epidural needle placement
The number of removal and insertion of the epidural needle until feeling epidural space.
1 secondary outcome
The number of needle insertion attempts
Time frame: Within 10 minutes during epidural needle placement
Results and safety
The study was stopped early (reason given: Manpower issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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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.
Seema Dave, MPH study director
University of Texas Southwestern Medical Center
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 image guidance and Landmark palpation in people with Labor Pain, run by University of Texas Southwestern Medical Center 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 5 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: stopped early, as of the sponsor's last update on 1 Jun 2022. 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?
The study was stopped early (reason given: Manpower issues). Results are not available in the source record.
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?
The time needed to complete epidural placements (time frame: Within 10 minutes during epidural needle 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 1 Jun 2022.