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

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NYU Langone Health

Status

Completed

Conditions

Epidural/Anesthesia

Treatments

Other: Cold Stimulus (Ice)

Study type

Interventional

Funder types

Other

Identifiers

NCT03437889
17-01532

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Epidural analgesia/anesthesia for childbirth
Experimental group
Treatment:
Other: Cold Stimulus (Ice)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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