UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044599 |
|---|---|
| Receipt number | R000050775 |
| Scientific Title | Efficacy of scheduled intravenous administration of acetaminophen for postoperative pain in patients after transurethral resection of bladder tumor: a randomized study |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2024/03/07 21:43:41 |
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Basic information
Public title
Efficacy of scheduled intravenous administration of acetaminophen for postoperative pain in patients after transurethral resection of bladder tumor: a randomized study
Acronym
Efficacy of scheduled intravenous administration of acetaminophen for postoperative pain in patients after transurethral resection of bladder tumor: a randomized study
Scientific Title
Efficacy of scheduled intravenous administration of acetaminophen for postoperative pain in patients after transurethral resection of bladder tumor: a randomized study
Scientific Title:Acronym
Efficacy of scheduled intravenous administration of acetaminophen for postoperative pain in patients after transurethral resection of bladder tumor: a randomized study
Region
| Japan |
Condition
Condition
Patient who undergone TURBT
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of scheduled intravenous administration of acetaminophen for postoperative pain in patients undergone TURBT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of catheter-related bladder discomfort at postoperative 0,1,2,4,8,12h
Score of catheter-related bladder discomfort is defined as follows:
1. No discomfort, 2. Mild: revealed on questioning only, 3. Moderate: stated by the patient without being questioned, 4. Severe: urinary urgency demonstrated by behavioral responses such as attempts to remove the urinary catheter, restless extremity movements, verbal responses.
Key secondary outcomes
Face Rating Scale at before TURBT, postoperative 0,1,2,4,8,12h, postoperative day1, day2, day3
Hematuria scale at postoperative 0,1,2,4,8,12h
Administration of additional analgesic after TURBT
Duration of urethral catheter after TURBT
Postoperative hospital stay
Rate of postoperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
scheduled intravenous administration of acetaminophen at postoperative 4,8,12h
Interventions/Control_2
administration of analgesic at the time of need
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who undergone TURBT
Key exclusion criteria
Patient who undergone other surgery at the same time
Patient who performed TURBT within 1 year
Patient contraindicated for acetaminophen
Patient with urethral cahteter
Patient who performing clean intermittent catheterization
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Mita |
Organization
Hiroshima-City Asa Citizens Hospital
Division name
Urology
Zip code
731-0293
Address
2-1-1 Kabeminami, Asakita-ku, Hiroshima, Hiroshima
TEL
082-815-5211
kojimitakojimita@gmail.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Hatayama |
Organization
Hiroshima-City Asa Citizens Hospital
Division name
Urology
Zip code
731-0293
Address
2-1-1 Kabeminami, Asakita-ku, Hiroshima, Hiroshima
TEL
082-815-5211
Homepage URL
htomoya1211@gmail.com
Sponsor or person
Institute
Hiroshima-City Asa Citizens Hospital, Urology
Institute
Department
Personal name
Funding Source
Organization
Hiroshima-City Asa Citizens Hospital, Urology
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
Hiroshima-City Asa Citizens Hospital
Address
2-1-1 Kabeminami, Asakita-ku, Hiroshima, Hiroshima
Tel
082-815-5211
at-sasaki@asa-hosp.city.hiroshima.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 | 06 | Month | 21 | 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
| 2021 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050775
