Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

NCT ID: NCT03317626

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-20
• Study Completion Date: 2018-02-05

Brief Summary

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.

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 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.

Conditions

Epidural Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold Stimulus

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

Group Type: EXPERIMENTAL

Cold Stimulus (ice) Test

Intervention Type: DIAGNOSTIC_TEST

Standard of care epidural will be inserted. The study procedure will be to use a cold stimulus (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. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

Interventions

Cold Stimulus (ice) Test

Standard of care epidural will be inserted. The study procedure will be to use a cold stimulus (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. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilbert Grant

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-00975

Identifier Type: -

Identifier Source: org_study_id