Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

NCT03317626 | Completed

• 1 other identifier: 17-00975
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cold Stimulus

EXPERIMENTAL

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

Diagnostic Test: Cold Stimulus (ice) Test

Interventions

Cold Stimulus (ice) Test 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.

Cold Stimulus

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women who have requested epidural analgesia for childbirth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients requesting epidural analgesia for labor
• ASA physical status I to II
• Ability to speak and read English to fully comprehend the consent process

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Ice

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Officials

• Gilbert Grant

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 23, 2017
• Study Start: September 20, 2017
• Primary Completion: February 5, 2018
• Study Completion: February 5, 2018
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

US (1)