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

Study Overview
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Brief Summary
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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.

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/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

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

Conditions
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Epidural/Anesthesia

Intervention / Treatment
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* Other: Cold Stimulus (Ice)


Participation Criteria
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Eligibility Criteria
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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

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural analgesia/anesthesia for childbirth<br> | Other: Cold Stimulus (Ice)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of bilateral decrease of sensation to cold with ice | 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. | 30 Minutes Post Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural