UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018770 |
|---|---|
| Receipt number | 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 03:34:38 |
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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
| Obstetrics 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
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
takahiro@nagoya-1st.jrc.or.jp
Sponsor or person
Institute
Nagoya university graduste school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021714
