Comparison of Loss of Resistance Techniques

October 11, 2018 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Air
Air 3 ml used to identify epidural space
Procedure: Air
3 mls used for identifying epidural space
Active Comparator: Saline
Saline 3 ml used to identify epidural space
Procedure: Saline
3 mls of saline used to identify epidural space

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Actual)

November 9, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Air versus Saline

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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