Completed

NCT Number: NCT03437889

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

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.

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Key information

Conditions

Epidural/Anesthesia

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Stimulus (Ice)

Other

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.

Primary outcomes

Measure of bilateral decrease of sensation to cold with ice

Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health