UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038599 |
|---|---|
| Receipt number | R000043990 |
| Scientific Title | A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy |
| Date of disclosure of the study information | 2019/12/21 |
| Last modified on | 2020/03/03 21:19:51 |
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Basic information
Public title
A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Acronym
A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Scientific Title
A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Scientific Title:Acronym
A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A multicenter randomized controlled trial will evaluate the non-inferiority of local anesthesia plus intravenous acetaminophen in postoperative analgesia to epidural anesthesia which is considered to be standard treatment, in patients undergoing laparoscopic gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with an NRS score of 4 or higher at 24 hours postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Control group: The patient is placed under epidural anesthesia during surgery, and epidural anesthesia is used for postoperative analgesia.
Interventions/Control_2
Intervention group: Wound local anesthesia is performed at the end of surgery, and intravenous acetaminophen is given as scheduled for 3 days after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven adenocarcinoma
of the stomach
2) Surgically resectable tumor (cStageI-III) by laparoscopic gastrectomy
3) Age 20 > years
4) ECOG performance status 0 or 1.
5) Cases with adequately maintained organ functions and fullfilling the following conditions within 4 weeks before registration.
WBC>3000
Plt>100000
AST<100
ALT<100
Total bilrbin<2.0mg/dL
Serum creatinine<1.5mg/dL
6) Written informed consent
Key exclusion criteria
1) Patients with synchronous or metachronous malignancies.
2) Inappropriate for epidural anesthesia
3) Patients with Hugh-Jones II or higher pulmonary disease
4) Unstable angina pectoris or history of myocardial infarction within 6 months.
5) Uncontrollable hypertension.
6) Uncontrollable diabetes mellitus
7) History of hypersensitivity of acetaminophen
8) History of hypersensitivity of ropivacaine hydrochloride hydrate or lidocaine hydrochloride
9) History of hypersensitivity of aspirin-induced asthma
10) Continuous systemic steroid therapy.
11) Women during pregnancy or breast feeding.
12) Judged inappropriate by the investigators
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Sachio |
| Middle name | |
| Last name | Fushida |
Organization
Kanazawa University
Division name
Gastroenterologic Surgery
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2362
fushida@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Kinoshita |
Organization
Kanazawa University
Division name
Gastroenterologic Surgery
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2362
Homepage URL
junkino0416@gmail.com
Sponsor or person
Institute
NPO Digestive Disease Support Organization (DDSO)
Institute
Department
Personal name
Funding Source
Organization
NPO Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa University
Address
13-1 Takara-machi, Kanazawa
Tel
076-265-2000
hpsangak@adm.kanazawa-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
| 2019 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2019 | Year | 11 | Month | 15 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043990
