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Comparison of Loss of Resistance Techniques
This study has been completed.
Study NCT00638274   Information provided by Wake Forest University
First Received: March 12, 2008   Last Updated: February 26, 2009   History of Changes

March 12, 2008
February 26, 2009
July 2005
May 2008   (final data collection date for primary outcome measure)
To compare whether air or saline makes a difference in the success and quality of labor pain relief when the combined spinal epidural is used to treat labor pain relief. [ Time Frame: evaluate at delivery for catheter success ] [ Designated as safety issue: No ]
To compare whether air or saline makes a difference in the success and quality of labor pain relief when the combined spinal epidural is used to treat labor pain relief. [ Time Frame: study end ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00638274 on ClinicalTrials.gov Archive Site
 
 
 
Comparison of Loss of Resistance Techniques
Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia

The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space.

When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure.

The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain.

 
Interventional
Other, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Pain Relief
  • Procedure: Air
  • Procedure: Saline
  • Active Comparator: Air 3 ml used to identify epidural space
  • Active Comparator: Saline 3 ml used to identify epidural space
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
350
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant females weighing less than or equal to 250 lbs
  • Request for neuraxial labor analgesia

Exclusion Criteria:

  • ASA physical status greater than II
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00638274
Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences
Air versus Saline
Wake Forest University
 
Principal Investigator: Peter H. Pan, MSEE, MD Wake Forest University
Wake Forest University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP