UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042210 |
|---|---|
| Receipt number | R000048181 |
| Scientific Title | Efficacy of pentazocine on pruritus during cesarean section due to spinal anesthesia-added opioids. |
| Date of disclosure of the study information | 2020/10/22 |
| Last modified on | 2021/05/20 11:05:36 |
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Basic information
Public title
Efficacy of pentazocine on pruritus during cesarean section due to spinal anesthesia-added opioids.
Acronym
Efficacy of pentazocine on pruritus during cesarean section.
Scientific Title
Efficacy of pentazocine on pruritus during cesarean section due to spinal anesthesia-added opioids.
Scientific Title:Acronym
Efficacy of pentazocine on pruritus during cesarean section.
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of pentazocine on pruritus during cesarean section.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the increase or decrease in the incidence of pruritus during cesarean section with pentazocine administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
pentazocine
Interventions/Control_2
droperidol
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
1. Patients with elective cesarean delivery under spinal anesthesia 2. American Society of Anesthesiologists physical status: 2-3 3. The patient is over 20 years old. 4. Obtaining consent form from patients
Key exclusion criteria
Emergency surgery. 2 Patients with allergy including fentanyl, morphine, pentazocine, and local anesthetic, droperidol. 3 Patient who already have pruritus.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Shinjo |
Organization
Nara Prefecture General Medical Center
Division name
Anesthesiology
Zip code
630-8054
Address
2-897-5,Shitizyonishi-machi,Nara
TEL
0742466001
tshinjo@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Shinjo |
Organization
Nara Prefecture General Medical Center
Division name
Anesthesiology
Zip code
630-8054
Address
2-897-5,Shitizyonishi-machi,Nara
TEL
0742466001
Homepage URL
tshinjo@hotmail.co.jp
Sponsor or person
Institute
Nara Prefecture General Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Nara Prefecture General Medical Center
Address
2-897-5,Shitizyonishi-machi,Nara
Tel
0742-46-6001
sogo@nara-hp.jp
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
| 2020 | Year | 10 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048181
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
