UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046804 |
|---|---|
| Receipt number | R000053402 |
| Scientific Title | A evaluation of the relevance between surgical types and the number of postoperative analgesic requirement in gynecological laparoscopic surgery: a retrospective observational study |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2023/03/10 08:58:12 |
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Basic information
Public title
A evaluation of the relevance between surgical types and the number of postoperative analgesic requirement in gynecological laparoscopic surgery: a retrospective observational study
Acronym
A evaluation of the relevance between surgical types and the number of postoperative analgesic requirement in gynecological laparoscopic surgery: a retrospective observational study
Scientific Title
A evaluation of the relevance between surgical types and the number of postoperative analgesic requirement in gynecological laparoscopic surgery: a retrospective observational study
Scientific Title:Acronym
A evaluation of the relevance between surgical types and the number of postoperative analgesic requirement in gynecological laparoscopic surgery: a retrospective observational study
Region
| Japan |
Condition
Condition
Gynecologic laparoscopic cases which were performed under general anesthesia in conjunction with wound infiltration analgesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although "gynecological laparoscopic surgery" includes various types of procedures, there are few studies evaluating postoperative analgesic requirements in each procedures.The purpose of this study is to evaluate the relevance of analgesic requirement between different types of gynecological laparoscopic surgeries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of request for the analgesic agent by the postoperative day one.
Key secondary outcomes
The degree of postoperative pain by the postoperative day one.
Intraoperative dose of fentanyl/remifentanil.
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. The patients undergoing gynecologic laparoscopic surgery from April 1st, 2019 to March 31st, 2021.
2. The patients receiving wound infiltration analgesia adjunct to general anesthesia (TIVA using propofol).
3. The patients who do not offer exclusion.
Key exclusion criteria
1. Emergency surgery.
2. The patient who do not receive intravenous flurbiprofen nor acetaminophen, or received both agents (Because this can influence the postoperative request for analgesics).
3. The case of anesthesia time >6 hours.
4. Other patients who are judged inappropriate by the investigator
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Aikawa |
Organization
Hokkaido university hospital
Division name
Anesthesiology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-716-1161
katsuhiro.aikawa@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Aikawa |
Organization
Hokkaido university hospital
Division name
Anesthesiology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
katsuhiro.aikawa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital, department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university hospital, department of anesthesiology
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
Hokkaido university hospital clinical research and medical innovation center
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-706-7636
katsuhiro.aikawa@med.hokudai.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
| 2022 | Year | 02 | Month | 03 | 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
61
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 | 02 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2022 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053402
