Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Cold Stimulus
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
Intervention: Cold Stimulus (ice) Test (Diagnostic Test)
Outcomes
Primary Outcomes
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported