UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019775 |
|---|---|
| Receipt number | R000022836 |
| Scientific Title | Assessing analgesia in single and repeated administrations of acetaminophen for postoperative pain after gynecologic laparoscopic surgery |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2019/04/03 23:40:37 |
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Basic information
Public title
Assessing analgesia in single and repeated administrations of acetaminophen for postoperative pain after gynecologic laparoscopic surgery
Acronym
Repeated vs single administrations of acetaminophen (gynecologic laparoscopic surgery)
Scientific Title
Assessing analgesia in single and repeated administrations of acetaminophen for postoperative pain after gynecologic laparoscopic surgery
Scientific Title:Acronym
Repeated vs single administrations of acetaminophen (gynecologic laparoscopic surgery)
Region
| Japan |
Condition
Condition
Ovarian desease
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We assess the effects and adverse effects of single and repeated administrations of acetaminophen for postoperative pain management after gynecologic laparoscopic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1) postoperative pain score (numerical rating scale: NRS) at 2, 4 hour at postoperative day (POD) 0, AAM and PM at POD 1 and 2
2) supplemental analgesia for 2 days
Key secondary outcomes
1) postoperative nausea and vomiting for 2 days
2) satisfaction of the patient using NRS at POD 2
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients in group R were administrated IV 1 g acetaminophen 4 times per day for 2 days postoperatively.
Interventions/Control_2
Patients in group S were administrated IV 1 g acetaminophen only once at the end of surgery.
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Patients with American Society of Anesthesiologists physical status 1-2 who were scheduled to undergo elective gynecologic laparoscopic surgery under general anesthesia.
Key exclusion criteria
1) Weighed < 40 or > 100 kg
2) Pregnancy
3) Having neurological, cardiovascular, and respiratory complications.
4) Allergy to amide local anesthetics or opioids4
5) Psychoactive medications
6) Hepatic or renal failure
7) Inability to understand the pain scale
8) Not obtained informed consent
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111(3568)
niiyama@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111(3568)
Homepage URL
niiyama@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
| 2015 | Year | 11 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022836
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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