Comparison of Loss of Resistance Techniques

NCT ID: NCT00638274

Last Updated: 2018-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Relief

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Air

Air 3 ml used to identify epidural space

Group Type ACTIVE_COMPARATOR

Air

Intervention Type PROCEDURE

3 mls used for identifying epidural space

Saline

Saline 3 ml used to identify epidural space

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type PROCEDURE

3 mls of saline used to identify epidural space

Interventions

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Air

3 mls used for identifying epidural space

Intervention Type PROCEDURE

Saline

3 mls of saline used to identify epidural space

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter H. Pan, MSEE, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Air versus Saline

Identifier Type: -

Identifier Source: org_study_id

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