UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000014872
Receipt number	R000017294
Scientific Title	A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section
Date of disclosure of the study information	2014/08/18
Last modified on	2018/08/24 12:01:30

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Basic information

Public title

A randomized,double-blind, parallel-group multicenter study for the effect of an epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Patient for elective cesarean section,with analgesic level is below Th7 five minutes after the spinal anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

We evaluate the efficacy of epidural top up with normal saline in combined spinal epidural anesthesia with isobaric bupivacaine for cesarean section

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Time to reach Th4 on analgesic level(pin prick test),the percentage of patients that attain the analgesic level with Th4,attained maximum analgesic level

Key secondary outcomes

Perioperative hemodynamics
Total consumption of vasopressor agent
Total consumption of intraoperative additional analgesic agent
Intraoperative nausea and vomiting
Volume of intraoperative urine, operation time, anesthesia time
Apgar score
Umbilical code blood gas analysis
Post dural puncture headache and post-operative nausea and vomiting
Total consumption of post-operative additional analgesics
Post-operative VAS scale

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver Other

Interventions/Control_1

Group for epidural injection with normal saline after 5.5 minutes of intrathecal isobaric bupivacaine

Interventions/Control_2

Group for none of epidural injection after intrathecal isobaric bupivacaine

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

20 years-old <=

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

Parturient for elective cesarean section
Analgesic level is below Th7 five minutes after the spinal anesthesia
American Society of Anesthesia(ASA)1-2

Key exclusion criteria

Emergency
Gestational period <37 or >42 weeks
Placenta previa
Multiplets
Severe PIH
Bleeding disorders and coagulopathy
Neuromuscular disease
Spinal disorder with anatomical spinal anomaly
A case of preliminary anesthetic treatment
Body weight => 90kg
Height < 150 and =>171 cm
Major fetal anomaly
Mental retardation
Patient without cooperation
History of allergy to local anesthetics

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Mitsuko Kinoshita

Organization

Yokohama City University School of Medicine

Division name

Department of anesthesiology and critical care medicine

Zip code

Address

3-9 Fukuura, Kanazawku, Yokohama, Kanagawa

TEL

045-787-2800

Email

anesthes@yokohama-cu.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Mitsuko Kinoshita

Organization

Yokohama City University School of Medicine

Division name

Department of anesthesiology and critical care medicine

Zip code

Address

3-9 Fukuura, Kanazawku, Yokohama, Kanagawa

TEL

045-787-2918

Homepage URL

Email

anesthes@yokohama-cu.ac.jp

Sponsor or person

Institute

Yokohama City University School of Medicine

Institute

Department

Personal name

Funding Source

Organization

None

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横浜市立大学附属病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立市民病院（神奈川県）
横浜労災病院（神奈川県）
帝京大学医学部附属溝口病院（神奈川県）

Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 18 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

2014 Year 07 Month 10 Day

Date of IRB

Anticipated trial start date

2014 Year 08 Month 18 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2014 Year 08 Month 16 Day

Last modified on

2018 Year 08 Month 24 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017294

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name