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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03437889

Enrollment

100

Registered

2018-02-19

Start date

2018-03-20

Completion date

2021-04-26

Last updated

2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural/Anesthesia

Keywords

epidural

Brief 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.

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/anesthesia for childbirth (vaginal and cesarean delivery) in women with a BMI greater than 30 kg/m2.

Interventions

OTHERCold 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026