UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050980 |
|---|---|
| Receipt number | R000058106 |
| Scientific Title | Anesthesia satisfaction survey of elective cesarean section with intrathecal morphine in patients who received combined spinal and epidural anesthesia for previous cesarean section. |
| Date of disclosure of the study information | 2023/05/02 |
| Last modified on | 2025/05/18 17:27:44 |
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Basic information
Public title
Anesthesia satisfaction survey of elective cesarean section with intrathecal morphine in patients who received combined spinal and epidural anesthesia for previous cesarean section.
Acronym
Anesthesia satisfaction survey for cesarean section.
Scientific Title
Anesthesia satisfaction survey of elective cesarean section with intrathecal morphine in patients who received combined spinal and epidural anesthesia for previous cesarean section.
Scientific Title:Acronym
Anesthesia satisfaction survey for cesarean section.
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey which anesthesia satisfaction is higher between spinal epidural combined anesthesia and spinal anesthesia with morphine.
Basic objectives2
Others
Basic objectives -Others
Anesthesia satisfaction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anesthesia satisfaction
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Patients undergoing cesarean section under spinal anesthesia.
2) Patients whose previous cesarean section anesthesia was spinal epidural combined anesthesia and whose postoperative analgesia method was continuous epidural analgesia.
3) Age 18 years or older at the time of consent.
4) Written consent to participate in the study has been obtained from the patient.
Key exclusion criteria
1)Extremely emergent cesarean section(We had no time for explanation).
2)Patients who have an allergy to morphine, fentanyl, or bupivacaine.
3)Anesthesia was changed due to inadequate anesthetic effect of spinl anesthesia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Uchimura |
Organization
National Hospital Organization Miyakonojo Medical Center
Division name
Department of Anesthesiology
Zip code
885-0014
Address
5033-1 Iwayoshi, Miyakonojo, Miyazaki
TEL
0986-23-4111
syuji_uchimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Uchimura |
Organization
National Hospital Organization Miyakonojo Medical Center
Division name
Department of Anesthesiology
Zip code
885-0014
Address
5033-1 Iwayoshi, Miyakonojo, Miyazaki
TEL
0986-23-4111
Homepage URL
syuji_uchimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
National Hospital Organization Miyakonojo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Miyakonojo Medical Center
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
The National Hospital Organization Miyakonojo Medical Center Institutional Committee on Ethics
Address
5033-1 Iwayoshi, Miyakonojo, Miyazaki
Tel
0986-23-4111
621-kanrika@mail.hosp.go.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
| 2023 | Year | 05 | Month | 02 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective questionnaire survey
Management information
Registered date
| 2023 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058106
