UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051708 |
|---|---|
| Receipt number | R000059014 |
| Scientific Title | A Prospective study of postoperative pain control using multimodal analgesia incorporated with temporary transversus abdominis plane block compared with epidural analgesia in laparoscopic colon cancer surgery. |
| Date of disclosure of the study information | 2023/07/27 |
| Last modified on | 2023/07/25 13:35:04 |
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Basic information
Public title
A Prospective study of postoperative pain control using multimodal analgesia incorporated with temporary transversus abdominis plane block compared with epidural analgesia in laparoscopic colon cancer surgery.
Acronym
A Prospective study of postoperative pain control using multimodal analgesia incorporated with temporary transversus abdominis plane block.
Scientific Title
A Prospective study of postoperative pain control using multimodal analgesia incorporated with temporary transversus abdominis plane block compared with epidural analgesia in laparoscopic colon cancer surgery.
Scientific Title:Acronym
A Prospective study of postoperative pain control using multimodal analgesia incorporated with temporary transversus abdominis plane block.
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This prospective, randomized study evaluated postoperative pain control with multimodal analgesia incorporated with temporary transversus abdominis plane block compared with epidural analgesia in laparoscopic colon cancer surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The primary evaluation point was frequencies of additional analgesics up to the postoperative day (POD) 2.
Key secondary outcomes
VAS score, blood pressure, time to bowel movement, time to mobilization, postoperative complications, and length of hospital stay.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Multimodal analgesia incorporated with TAP block group.
Interventions/Control_2
Epidural analgesia
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who could safely receive general anesthesia and surgery, have Eastern Cooperative Oncology Group performance status (ECOG-PS)0-2
Age at registration is ranging from 20 to 85 yeares old.
The written agreement including a signature and the date is provided.
Key exclusion criteria
ECOG-PS more than 3, emergent surgery, rectal resection, contra-indication of EA, severe comorbidities, history of psychiatric disorder, age less than 20 years and more than 85 years, pregnant women,
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Manabe |
| Middle name | |
| Last name | Tatsuya |
Organization
Saga University
Division name
Surgery
Zip code
8498501
Address
5-1-1 Nabeshima, Saga, Saga
TEL
0952-34-2349
manabe@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Manabe |
| Middle name | |
| Last name | Tatsuya |
Organization
Saga University
Division name
Surgery
Zip code
8498501
Address
5-1-1 Nabeshima, Saga, Saga
TEL
0952342349
Homepage URL
manabe@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
5-1-1 Nabeshima, Saga,
Tel
09071581885
manabe@cc.saga-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
| 2023 | Year | 07 | 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
58
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 25 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059014
