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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046207
Receipt No. R000052513
Scientific Title A comparison of the postoperative analgesic efficiency between M-TAPA and wound infiltration analgesia in gynecologic laparoscopic surgery: a retrospective observational study.
Date of disclosure of the study information 2021/11/27
Last modified on 2021/11/27

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Basic information
Public title A comparison of the postoperative analgesic efficiency between M-TAPA and wound infiltration analgesia in gynecologic laparoscopic surgery: a retrospective observational study.
Acronym A comparison of the postoperative analgesic efficiency between M-TAPA and wound infiltration analgesia in gynecologic laparoscopic surgery: a retrospective observational study.
Scientific Title A comparison of the postoperative analgesic efficiency between M-TAPA and wound infiltration analgesia in gynecologic laparoscopic surgery: a retrospective observational study.
Scientific Title:Acronym A comparison of the postoperative analgesic efficiency between M-TAPA and wound infiltration analgesia in gynecologic laparoscopic surgery: a retrospective observational study.
Region
Japan

Condition
Condition Gynecologic laparoscopic cases which were performed under general anesthesia in conjunction with M-TAPA or wound infiltration analgesia.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To date, there are no study evaluating the analgesic efficacy between M-TAPA and existing method. The purpose of this study is to compare the analgesic efficacy between M-TAPA and wound infiltration analgesia retrospectively in gynecologic laparoscopic surgery.
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 Presence or absence of adverse events

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 January 2020 to July 2021.
2. The patients receiving M-TAPA or wound infiltration analgesia adjunct to general anesthesia.
3. The patients who do not offer exclusion.
Key exclusion criteria 1. Age =>20 or =<70 at the time point of surgery.
2. Emergency surgery.
3. The patient who do not receive intravenous flurbiprofen nor acetaminophen, or received both agents (Because this can influence the postoperative request for analgesics).
4. Other patients who are judged inappropriate by the investigator
Target sample size 90

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
Email 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
Email katsuhiro.aikawa@med.hokudai.ac.jp

Sponsor
Institute Hokkaido university hospital, department of anesthesiology
Institute
Department

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
Email 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
2021 Year 11 Month 27 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
2021 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 13 Day
Last follow-up date
2021 Year 12 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
2021 Year 11 Month 27 Day
Last modified on
2021 Year 11 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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