Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03317626

Collaborator

(none)

100

Enrollment

Location

Arm

4.5

Actual Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Sep 20, 2017

Actual Primary Completion Date :

Feb 5, 2018

Actual Study Completion Date :

Feb 5, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Gilbert Grant, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03317626

Other Study ID Numbers:

17-00975

First Posted:

Oct 23, 2017

Last Update Posted:

Nov 14, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Nov 14, 2019