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CompletedNCT03317626Updated Nov 14, 2019

Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

An interventional study of Cold Stimulus (ice) Test in Epidural Anesthesia, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-14.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Epidural Anesthesia
03

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • Diagnostic testCold 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 Minutes post intervention

06

Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
07

Registry details

Key details

Study ID
NCT03317626
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Sep 20, 2017
Primary completion
Feb 5, 2018
Completion
Feb 5, 2018
Last update
Nov 14, 2019

Study contacts

Gilbert Grant
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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