UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidural analgesia: a randomized clinical trial comparing loss of resistance to saline versus low volume of air
Title of the study (Brief title)	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	Leopoldo E. Ferrer
Organization	Fundacion Santa Fe de Bogota
Division name	Anesthesia Department
Address	Carrera 7 No. 117-15, Bogota, Colombia
TEL	+5716030303
Email	lfanesthesia@gmail.com

Public contact
Name of contact person	Leopoldo E. Ferrer
Organization	Fundacion Santa Fe de Bogota
Division name	Anesthesia Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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