UMIN-CTR Clinical Trial

Basic information
Public title	Randomized clinical trial on epidural versus patient-controlled intravenous analgesia on postoperative pain control after laparoscopic gastrectomy
Acronym	Randomized clinical trial on postoperative pain control after laparoscopic gastrectomy
Scientific Title	Randomized clinical trial on epidural versus patient-controlled intravenous analgesia on postoperative pain control after laparoscopic gastrectomy
Scientific Title:Acronym	Randomized clinical trial on postoperative pain control after laparoscopic gastrectomy
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To verify the noninferiority of patient-controlled intravenous analgesia to epidural analgesia on pain management after laparoscopic gastrectomy for gastric cancer
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Postoperative pain at rest 24 h after surgery
Key secondary outcomes	The achievement day of discharge criteria, Length of postoperative hospital stay, Postoperative complications, Postoperative pain on day 2,3,4 after surgery, Additional doses of analgesics, Adverse events related to analgesia, Patients' satisfaction

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Epidural analgesia (EDA) Epidural catheter is inserted at thoracic level (Th8-Th10) before induction of anesthesia. At the end of surgery, a solution of bupivacaine (0.1%), fentanyl (1 mug/mL) is initiated in the epidural group at a rate of 2 to 6 mL/ h with bolus of 3 mL of the solution allowed every 15 minutes (patient-controlled epidural analgesia). EDA is planned to be discontinued on postoperative day (POD) 2, but EDA can be continued until POD 7 if the analgesia team judged that a prolonged application is beneficial for the patient.
Interventions/Control_2	Patient-controlled opioid based intravenous analgesia (PCA) Intravenous fentanyl (10 mug/mL) is inserted with 1 ml/h. A bolus of 1 mL is allowed at every 15 minutes up to a maximal dose of 40 mug/h. PCA is planned to be discontinued on postoperative day (POD) 2, but PCA can be continued until POD 7 if the analgesia team judged that a prolonged application is beneficial for the patient.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Gastric cancer patients who are planned to undergo laparoscopic gastrectomy including total gastrectomy, distal gastrectomy, and proxymal gastrectomy. 2) Patient's age is between 20 and 80 years old. 3) Before participation, patients receive information about the study and provide their written consent.
Key exclusion criteria	1) The patients whose preoperative peformance status more than ASA(American Society of Anestheists) IV 2) The patients undergoing anticoagulant therapy 3) Medical contraindication for epidural analgesia 4) Abnormal anatomy of the spinal column 5) Neoadjuvant chemotherapy 6) Immunodeficiency 7) Palliative surgery 8) Emergency surgery 9) Unsuitable patients for enrollment judged by the investigator
Target sample size	132

Research contact person
Name of lead principal investigator	1st name Toshiyoshi Middle name Last name Fujiwara
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Gastroenterological surgery
Zip code	700-8558
Address	2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7257
Email	toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Kikuchi
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Gastroenterological surgery
Zip code	700-8558
Address	2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL	086-235-7257
Homepage URL
Email	satorukc@okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	The Okayama Medical Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-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	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 01 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	132
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	2017 Year 05 Month 25 Day
Date of IRB	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date	2021 Year 01 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	2017 Year 06 Month 05 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030709

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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