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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026851
Receipt No. 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

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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 Obsterics 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
Institute Fundacion Santa Fe de Bogota
Institute
Department

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
URL(English) https://upload.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


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