Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Conditions
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Epidural Anesthesia

Intervention / Treatment
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* Diagnostic Test: Cold Stimulus (ice) Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Stimulus<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 Minutes post intervention |