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

Not Applicable

Completed

• Conditions: Epidural/Anesthesia
• Interventions: Other: Cold Stimulus (Ice)

• Registration Number: NCT03437889
• Lead Sponsor: NYU Langone Health

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.

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 Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-19
• Study Start: 2018-03-20
• Primary Completion: 2021-04-26
• Study Completion: 2021-04-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural analgesia/anesthesia for childbirth	Cold Stimulus (Ice)	-

Primary Outcome Measures

Name	Time	Method
Measure of bilateral decrease of sensation to cold with ice	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States