UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045935 |
|---|---|
| Receipt number | R000052435 |
| Scientific Title | A cohort study to investigate the relationship between Analgesia Nociception Index and local anesthetic infiltration pain in pregnant women undergoing elective cesarean section |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2024/11/01 14:16:28 |
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Basic information
Public title
A cohort study to investigate the relationship between Analgesia Nociception Index and local anesthetic infiltration pain in pregnant women undergoing elective cesarean section
Acronym
A cohort study to investigate the relationship between Analgesia Nociception Index and local anesthetic infiltration pain in pregnant women undergoing elective cesarean section
Scientific Title
A cohort study to investigate the relationship between Analgesia Nociception Index and local anesthetic infiltration pain in pregnant women undergoing elective cesarean section
Scientific Title:Acronym
A cohort study to investigate the relationship between Analgesia Nociception Index and local anesthetic infiltration pain in pregnant women undergoing elective cesarean section
Region
| Japan |
Condition
Condition
A pregnant woman undergoing elective cesarean delivery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the thresholds of the Analgesia Nociception Index, which discriminates the severity of local anesthetic infiltration pain as assessed by the Verbal Numerical Rating Scale.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the thresholds of the analgesia nociception Index, which discriminates the severity of local anesthetic infiltration pain as assessed by the Verbal Numerical Rating Scale.
Key secondary outcomes
To investigate the relationship between Analgesia Nociception Index and local anesthetic infiltration pain.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
A pregnant woman undergoing elective cesarean delivery
Key exclusion criteria
Patients who have difficulty or inability to communicate
Patients who are scheduled to undergo cesarean delivery with general anesthesia
Patients who are allergic to local anesthetics
Patients who are in some kind of pain.
Patients who are taking analgesic medication.
Patients who are chronically taking medication (except for supplements such as vitamins)
Patients with psychiatric disorders
Patients with preoperative ECG abnormalities
Patients with hypertensive disorder of pregnancy
Patients with BMI above 35
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TOSHIYUKI |
| Middle name | |
| Last name | OKUTOMI |
Organization
School of medicine, Kitasato university
Division name
Division of obstetric anesthesiology, Kitasato university hospital
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
tokutomi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROAKI |
| Middle name | |
| Last name | KONDO |
Organization
School of medicine, Kitasato university
Division name
Division of obstetric anesthesiology, Kitasato university hospital
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
hkondo@kitasato-u.ac.jp
Sponsor or person
Institute
School of medicine, Kitasato university
Institute
Department
Personal name
Funding Source
Organization
School of medicine,Kitasato university
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
Kitasato University School of Medicine
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinri@med.kitasato-u.ac.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
| 2021 | Year | 11 | 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
56
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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2021 | Year | 10 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052435
