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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035096
Receipt No. R000040009
Official scientific title of the study Identification of effective morphine administration route for postoperative pain in robot-assisted rectal resection (prospective intervention, open label test)
Date of disclosure of the study information 2018/12/03
Last modified on 2018/12/01

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Basic information
Official scientific title of the study Identification of effective morphine administration route for postoperative pain in robot-assisted rectal resection
(prospective intervention, open label test)
Title of the study (Brief title) Identification of effective morphine administration route for robot-assisted rectal resection
Region
Japan

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

Objectives
Narrative objectives1 Clarify the usefulness of morphine via continuous epidural administration in postoperative pain management of robot-assisted rectal resection compared with morphine iv-PCA
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analgesia from postoperatve day(PID)0 to POD 2
pain score
the consumption of morphine and additional
analgesics

recovery of bowel function from POD 0 to POD 2
Key secondary outcomes adverse effects from POD 0 to POD 2
postoperative nausea and vomiting
sedation
respiratory defect

patient's satisfaction at POD 1, 2
using QoR-40 sheets

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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
Maneuver
Interventions/Control_1 from POD 0 - POD 2
route of administration of morphine
continuous epidural infusion (0.26 mg /day)
Interventions/Control_2 from POD 0 - POD 2
iv-PCA(continuous infusion: none, bolus: 1 mg, lockout time: 15 min)
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria ASA-PS I-II
Key exclusion criteria case of ASA-PS > III
case of body weight < 40 kg
case of BMI > 35 kg/m2
Bronchial asthma, emphysema complicated case
Heart failure case
Liver / kidney disfunction case
ECG abnormal case (QT extension etc.)
Patients with Parkinson's disease
Alcohol and drug abuse history cases
Cases with a history of allergy to morphine, local anesthetics and other analgesics
Cases who consent can not be obtained
Target sample size 48

Research contact person
Name of lead principal investigator Yukitoshi Niiyama
Organization Sapporo Medical University, School of Medicine
Division name Department of Anesthesiology
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-611-2111(35680)
Email niiyama@sapmed.ac.jp

Public contact
Name of contact person Yukitoshi Niiyama
Organization Sapporo Medical University, School of Medicine
Division name Department of Anesthesiology
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-611-2111(35680)
Homepage URL
Email niiyama@sapmed.acjp

Sponsor
Institute Sapporo Medical University School of Medicine Clinical Department
Institute
Department

Funding Source
Organization Sapporo medical university school of medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 12 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 10 Day
Anticipated trial start date
2018 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040009

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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