Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Epidural Anesthesia Clinical Trial

Official title:

Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317626
• Other study ID #: 17-00975
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: February 5, 2018

Study information

• Verified date: November 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 5, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Anesthesia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.	Success will be defined as a bilateral decrease of sensation (hypesthesia) to cold and ice in at least 2 adjacent dermatomes between T8 and L2	30 Minutes post intervention