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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018770
Receipt No. R000021714
Scientific Title Postoperative analgesic effect in cesarean section.
Date of disclosure of the study information 2015/09/01
Last modified on 2019/05/06

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Basic information
Public title Postoperative analgesic effect in cesarean section.
Acronym Postoperative analgesic effect in cesarean section.
Scientific Title Postoperative analgesic effect in cesarean section.
Scientific Title:Acronym Postoperative analgesic effect in cesarean section.
Region
Japan

Condition
Condition All situation of mother's and fetus for Cesarean section with spinal anesthesia.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Postoperative analgesic effect with or without Morphine and TAP block.
(TAP block means QLB2, posterior QLB)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes post operative NRS VAS score after 4 hours
Key secondary outcomes Evaluation of postoeprative chronic pain

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 spinal anesthesia without Morphine and TAP block
(TAP block means QLB2, posterior QLB)
Interventions/Control_2 spinal anesthesia without Morphine and with TAP block
(TAP block means QLB2, posterior QLB)
Interventions/Control_3 spinal anesthesia with Morphine and without TAP block
(TAP block means QLB2, posterior QLB)
Interventions/Control_4 spinal anesthesia with Morphine and TAP block
(TAP block means QLB2, posterior QLB)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Cesarean section with spinal anesthesia and to cut lower abdomen across.
Key exclusion criteria can't get informed concent.
asa ps overthree.
BMI>35.
Cesarean section with general anesthesia.
Super emergency Cesarean section.
central or pheriferal nerve neuropathy.
coagulopathy and PT-INR>1.5 or APTT>50 and Plat < 100000.
heart liver and renal disease.
sever dm.
allergy for ropivacaine.
the case that anesthesiologist judged inappropriate.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Tamura
Organization Japanease red cross nagoya daiichi hospital
Division name Department of anesthesia
Zip code
Address 35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL 052-481-5111
Email takahiro@nagoya-1st.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Tamura
Organization Japanease red cross nagoya daiichi hospital
Division name Department of anesthesia
Zip code
Address 35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL 052-481-5111
Homepage URL
Email takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute Nagoya university graduste school of medicine
Institute
Department

Funding Source
Organization Nagoya university graduste school of medicine
Organization
Division
Category of Funding Organization Other
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 Japanese Red Cross Nagoya Daiichi hospital

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 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
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 14 Day
Last follow-up date
2017 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 23 Day
Last modified on
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021714

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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