UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026851
Receipt number R000030815
Scientific Title Epidural analgesia: a randomized clinical trial comparing loss of resistance to saline versus low volume of air
Date of disclosure of the study information 2017/04/03
Last modified on 2017/04/03 22:39:42

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Basic information

Public title

Epidural analgesia: a randomized clinical trial comparing loss of resistance to saline versus low volume of air

Acronym

Epidural loss of resistance with saline and air

Scientific Title

Epidural analgesia: a randomized clinical trial comparing loss of resistance to saline versus low volume of air

Scientific Title:Acronym

Epidural loss of resistance with saline and air

Region

South America


Condition

Condition

Labor

Classification by specialty

Medicine in general Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare loss of resistance using saline and air less or equal thab 3 mL regarding successful epidural space identification, pain control, maternal satisfaction, characteristics of blockade, and incidence of complications

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Successful epidural catheter placement

Key secondary outcomes

pain control, maternal satisfaction, characteristics of blockade, and side effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment Maneuver

Interventions/Control_1

Loss of resistance at epidural space was achieved with a syringe filled with less than 3 mL of air. Once epidural space was located, 3 mL of saline was injected through the needle.

Interventions/Control_2

loss of resistance at epidural space was achieved with a syringe filled with 3 mL of saline which were injected totally into epidural space, a 20 G catheter was introduced 4-7 cm into epidural space in cephalic direction and aspirating to evaluate blood or cerebrospinal fluid return.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

40 years-old >

Gender

Female

Key inclusion criteria

Laboring term patients aged 18-40 years requiring epidural analgesia.

Key exclusion criteria

Patients classified as American Society of Anesthesiology physical status more than 3, presence of allergies to local anesthetics, idiosyncratic reactions to opioids, contraindication for neuraxial analgesia or hemodynamic instability.

Target sample size

208


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Leopoldo E. Ferrer

Organization

Fundacion Santa Fe de Bogota

Division name

Anesthesia Department

Zip code


Address

Carrera 7 No. 117-15, Bogota, Colombia

TEL

+5716030303

Email

lfanesthesia@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Leopoldo E. Ferrer

Organization

Fundacion Santa Fe de Bogota

Division name

Anesthesia Department

Zip code


Address

Carrera 7 No. 117-15, Bogota, Colombia

TEL

+5716030303

Homepage URL


Email

lfanesthesia@gmail.com


Sponsor or person

Institute

Fundacion Santa Fe de Bogota

Institute

Department

Personal name



Funding Source

Organization

Fundacion santa fe de bogota

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2009 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 06 Month 10 Day

Last follow-up date

2012 Year 06 Month 01 Day

Date of closure to data entry

2012 Year 08 Month 10 Day

Date trial data considered complete

2013 Year 02 Month 01 Day

Date analysis concluded

2014 Year 04 Month 10 Day


Other

Other related information



Management information

Registered date

2017 Year 04 Month 03 Day

Last modified on

2017 Year 04 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030815


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name