Epidural AnesthesiaNCT03317626
Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
A study testing Cold Stimulus (ice) Test in people with Epidural Anesthesia, run by NYU Langone Health at 1 site in United States.
Trial summary
Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures. The gravity flow technique is not well known, and is therefore used in only a few hospitals. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Anesthesia
- What is being tested?
- Cold Stimulus (ice) Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 5 Feb 2018
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients requesting epidural analgesia for labor
- ASA physical status I to II
- Ability to speak and read English to fully comprehend the consent process
Who cannot join
- Combined spinal-epidural anesthesia
- Coagulopathy
- History of lumbar spine surgery
- Allergy or contraindication to any of the study medications
- Contraindication to epidural analgesia
- ASA physical status >III
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures.
The gravity flow technique is not well known, and is therefore used in only a few hospitals. The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women.
Read the detailed description
The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women. This gravity flow technique was first described 26 years ago in 1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been formally studied and this study is designed to enable assessment of the success rate of the gravity flow technique.
- Conditions
- Epidural Anesthesia
- Being tested
- Cold Stimulus (ice) Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Stimulus (ice) TestDiagnostic test
Standard of care epidural will be inserted. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.
| Study group | Role | What they receive |
|---|---|---|
| Cold Stimulus | Experimental | The study procedure will beto use a coldstimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted Receives: Diagnostic Test: Cold Stimulus (ice) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.
Success will be defined as a bilateral decrease of sensation (hypesthesia) to cold and ice in at least 2 adjacent dermatomes between T8 and L2
Measured: 30 Minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start20 Sep 2017
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilbert Grant, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317626
- Sponsor's protocol ID
- 17-00975
- Status last verified
- Nov 2019
- First submitted
- 17 Oct 2017
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
- ClinicalTrials.gov ID
- NCT03317626
- Acronym / sponsor ID
- 17-00975
- Conditions
- Epidural Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 23 Oct 2017 (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.
Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures.
The gravity flow technique is not well known, and is therefore used in only a few hospitals. The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women.
Detailed description
The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women. This gravity flow technique was first described 26 years ago in 1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been formally studied and this study is designed to enable assessment of the success rate of the gravity flow technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cold Stimulus | Experimental | Diagnostic Test: Cold Stimulus (ice) TestThe study procedure will beto use a coldstimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients requesting epidural analgesia for labor
- ASA physical status I to II
- Ability to speak and read English to fully comprehend the consent process
Key exclusion criteria (6 listed)
- Combined spinal-epidural anesthesia
- Coagulopathy
- History of lumbar spine surgery
- Allergy or contraindication to any of the study medications
- Contraindication to epidural analgesia
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 |
|---|---|---|
| Cold Stimulus (ice) TestStandard of care epidural will be inserted. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block. | Diagnostic test | Cold Stimulus |
Primary outcome
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.
Time frame: 30 Minutes post intervention
Success will be defined as a bilateral decrease of sensation (hypesthesia) to cold and ice in at least 2 adjacent dermatomes between T8 and L2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
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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.
Gilbert Grant principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Stimulus (ice) Test in people with Epidural Anesthesia, run by NYU Langone Health 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 6 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 14 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women. (time frame: 30 Minutes post intervention). 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 14 Nov 2019.