Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

NYU Langone Health

Status: Completed

Conditions: Epidural Anesthesia

Treatments: Diagnostic Test: Cold Stimulus (ice) Test

Study type: Interventional

Funder types: Other

Identifiers

NCT03317626

17-00975

Details and patient eligibility

About

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.

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 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Cold Stimulus

Experimental group

Description:

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

Treatment:

Diagnostic Test: Cold Stimulus (ice) Test