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Completed

NCT Number: NCT00638274

Comparison of Loss of Resistance Techniques

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.

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Key information

Conditions

Pain Relief

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

air

Procedure

3 mls used for identifying epidural space

Saline

Procedure

3 mls of saline used to identify epidural space

Primary outcomes

  1. Success of Spinal Labor Analgesia From Combined Spinal Epidural

    Time frame: 24 hours

    Number of participants that had successful spinal labor analgesia in each group.

Secondary outcomes

  1. Number of Participants With Failed Epidural Catheters

    Time frame: 24 hours

    Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 19, 2008
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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