UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027643 |
|---|---|
| Receipt number | 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 | 2021/06/08 21:15:37 |
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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
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
satorukc@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Completed
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
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030709
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