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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer 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 | 2020/12/07 |
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 |
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Condition | |||
Condition | Gastric cancer | ||
Classification by specialty |
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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 |
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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. |
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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. |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 132 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |