Comparison of Loss of Resistance Techniques

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00638274
First received: March 12, 2008
Last updated: February 26, 2009
Last verified: February 2009
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 School of Medicine:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
Investigators
Principal Investigator: Peter H. Pan, MSEE, MD Wake Forest School of Medicine
  More Information

No publications provided

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

Keywords provided by Wake Forest School of Medicine:
Quality of pain relief with 2 different methods of identifying epidural space

ClinicalTrials.gov processed this record on October 29, 2014