Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03317626

Enrollment

100

Registered

2017-10-23

Start date

2017-09-20

Completion date

2018-02-05

Last updated

2019-11-14

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

Conditions

Epidural Anesthesia

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.

Interventions

DIAGNOSTIC_TESTCold 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 49 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.	30 Minutes post intervention	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

Countries

United States

Outcome results

None listed

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