Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03317626|
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : November 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Epidural Anesthesia||Diagnostic Test: Cold Stimulus (ice) Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip|
|Actual Study Start Date :||September 20, 2017|
|Actual Primary Completion Date :||February 5, 2018|
|Actual Study Completion Date :||February 5, 2018|
Experimental: 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
Diagnostic Test: Cold 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317626
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Gilbert Grant||NYU Langone Health|