UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039505 |
|---|---|
| Receipt number | R000045053 |
| Scientific Title | Scheduled intravenous acetaminophen versus thoracic epidural analgesia for postoperative pain control after minimally invasive gastrectomy: a multicenter randomized non-inferiority trial |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2025/11/15 20:46:09 |
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Basic information
Public title
Scheduled intravenous acetaminophen versus thoracic epidural analgesia for postoperative pain control after minimally invasive gastrectomy: a multicenter randomized non-inferiority trial
Acronym
Scheduled intravenous acetaminophen versus thoracic epidural analgesia for postoperative pain control after minimally invasive gastrectomy: a multicenter randomized non-inferiority trial
Scientific Title
Scheduled intravenous acetaminophen versus thoracic epidural analgesia for postoperative pain control after minimally invasive gastrectomy: a multicenter randomized non-inferiority trial
Scientific Title:Acronym
Scheduled intravenous acetaminophen versus thoracic epidural analgesia for postoperative pain control after minimally invasive gastrectomy: a multicenter randomized non-inferiority trial
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The ojjective of this trial is to determine whether a scheduled intravenous acetaminophen-based multimodal analgesic regimen is non-inferior to TEA for postoperative pain control after minimally invasive gastrectomy for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The proportion of patients with a resting NRS score of 4 or higher at 24 hours after surgery
Key secondary outcomes
1.Pain-related outcomes
Area under the NRS-time curve during the first 72 hours (AUC72)
Time course of NRS scores at rest and during coughing
Number of rescue analgesic doses through POD3
Patient satisfaction assessed using a 7-point Likert scale (1-7)
2.Operative and anesthetic variables
Operative time and anesthetic time
3.Postoperative recovery outcomes
Time to first flatus and defecation
Time to ambulation
Time to urinary catheter removal
Length of postoperative hospital stay
4.Safety outcomes
Incidence and severity of analgesia-related adverse events
Incidence and severity of postoperative surgical complications (Clavien-Dindo classification)
Laboratory abnormalities, including hepatotoxicity, graded by CTCAE v4.0
5.Exploratory (post hoc) analyses
Proportion of patients with an NRS score >=4 at rest (48 and 72 hours) and during coughing (24, 48, and 72 hours)
(These exploratory analyses were added after study completion to ensure transparency and did not alter the study conduct or interpretation.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
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
Gastrointestinal Cancer Conference study group
Institute
Department
Personal name
Funding Source
Organization
Gastrointestinal Cancer Conference study group
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
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
| 2020 | Year | 03 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 27 | 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
| 2020 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045053
