NCT00638274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
10.5 years until next milestone

Results Posted

Study results publicly available

November 9, 2018

Completed
Last Updated

November 9, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

March 12, 2008

Results QC Date

September 5, 2018

Last Update Submit

October 11, 2018

Conditions

Pain Relief

Keywords

Quality of pain relief with 2 different methods of identifying epidural space

Outcome Measures

Primary Outcomes (1)

  • Success of Spinal Labor Analgesia From Combined Spinal Epidural

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

    24 hours

Secondary Outcomes (1)

  • Number of Participants With Failed Epidural Catheters

    24 hours

Study Arms (2)

Air

ACTIVE COMPARATOR

Air 3 ml used to identify epidural space

Procedure: Air

Saline

ACTIVE COMPARATOR

Saline 3 ml used to identify epidural space

Procedure: Saline

Interventions

AirPROCEDURE

3 mls used for identifying epidural space

Air
SalinePROCEDURE

3 mls of saline used to identify epidural space

Saline

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant females weighing less than or equal to 250 lbs
  • Request for neuraxial labor analgesia

You may not qualify if:

  • ASA physical status greater than II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Interventions

AirSodium Chloride

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Peter H. Pan, MD
Organization
Wake Forest University School of Medicine
ppan@wakehealth.edu
336-718-82748

Study Officials

  • Peter H. Pan, MSEE, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2008

First Posted

March 19, 2008

Study Start

July 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 9, 2018

Results First Posted

November 9, 2018

Record last verified: 2018-10

Locations

US(1)