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

Epidural/Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437889
• Other study ID #: 17-01532
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: April 26, 2021

Study information

• Verified date: November 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural/Anesthesia

Intervention

Other:
• Cold Stimulus (Ice)
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.

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	Measure of bilateral decrease of sensation to cold with ice	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.	30 Minutes Post Intervention