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Comparison of Loss of Resistance Techniques

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ClinicalTrials.gov Identifier: NCT00638274
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pain Relief Procedure: Air Procedure: Saline

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia
Study Start Date : July 2005
Primary Completion Date : May 2008
Study Completion Date : May 2008
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Air 3 ml used to identify epidural space
Procedure: Air
3 mls used for identifying epidural space
Active Comparator: 2
Saline 3 ml used to identify epidural space
Procedure: Saline
3 mls of saline used to identify epidural space


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

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): NCT00638274


Locations
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Peter H. Pan, MSEE, MD Wake Forest University Health Sciences
More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00638274     History of Changes
Other Study ID Numbers: Air versus Saline
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: February 2017

Keywords provided by Wake Forest University Health Sciences:
Quality of pain relief with 2 different methods of identifying epidural space