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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027643
Receipt No. R000030709
Scientific Title Randomized clinical trial on epidural versus patient-controlled intravenous analgesia on postoperative pain control after laparoscopic gastrectomy
Date of disclosure of the study information 2017/07/01
Last modified on 2019/06/28

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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
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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
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
2019 Year 06 Month 28 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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