Comparison of Loss of Resistance Techniques - Full Text View

Sponsored by:	Wake Forest University
Information provided by:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT00638274

Purpose

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.

Condition	Intervention
Pain Relief	Procedure: Air Procedure: Saline

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia

Further study details as provided by Wake Forest University:

Primary Outcome Measures:

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 ]

Enrollment:	350
Study Start Date:	July 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Air 3 ml used to identify epidural space	Procedure: Air 3 mls used for identifying epidural space
2: Active Comparator Saline 3 ml used to identify epidural space	Procedure: Saline 3 mls of saline used to identify epidural space

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638274

Locations

United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:

Peter H. Pan, MSEE, MD

Wake Forest University

More Information

No publications provided

Responsible Party:	Wake Forest University Health Sciences ( Peter H. Pan, MSEE, MD )
Study ID Numbers:	Air versus Saline
Study First Received:	March 12, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00638274 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Wake Forest University:

Quality of pain relief with 2 different methods of identifying epidural space

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 10, 2009