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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name