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Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03317626
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Epidural Anesthesia Diagnostic Test: Cold Stimulus (ice) Test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : February 5, 2018
Actual Study Completion Date : February 5, 2018

Arm Intervention/treatment
Experimental: Cold Stimulus
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
Diagnostic Test: Cold Stimulus (ice) 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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women who have requested epidural analgesia for childbirth
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients requesting epidural analgesia for labor
  • ASA physical status I to II
  • Ability to speak and read English to fully comprehend the consent process

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317626


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Gilbert Grant NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03317626    
Other Study ID Numbers: 17-00975
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No