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Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients

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ClinicalTrials.gov Identifier: NCT03437889
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
Pregnant women, with a Body Mass Index (BMI) greater than 30 kg/m2, who receive epidural analgesia/anesthesia for childbirth will have epidural catheter placement per our standard procedure, which includes using the gravity flow technique to confirm that the tip (aperture) of the epidural needle is indeed located within the epidural space. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

Condition or disease Intervention/treatment Phase
Epidural/Anesthesia Other: Cold Stimulus (Ice) 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/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip on Obese Parturients
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: Epidural analgesia/anesthesia for childbirth Other: Cold Stimulus (Ice)
The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted.




Primary Outcome Measures :
  1. Measure of bilateral decrease of sensation to cold with ice [ Time Frame: 30 Minutes Post Intervention ]
    Loss of sensation to ice; Following epidural procedure, subjects will be assessed to see if their epidural analgesia is working by determining if they have hyperthesia to ice on lower abdomen.



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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:   Patients requesting epidural analgesia/anesthesia for childbirth
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requesting epidural analgesia/anesthesia for childbirth
  • American Society of Anesthesiologists (ASA) physical status I to III
  • Ability to speak and read English to fully comprehend the consent process
  • BMI greater than 30 kg/m2

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
  • BMI less than 30 kg/m2

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): NCT03437889


Contacts
Contact: Lola Franco 212 263 0531 lola.franco@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Lola Franco    212-263-0531    lola.franco@nyumc.org   
Principal Investigator: Gilbert Grant, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Gilbert Grant, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03437889     History of Changes
Other Study ID Numbers: 17-01532
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
epidural