UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035096 |
|---|---|
| Receipt number | R000040009 |
| Scientific Title | 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 10:02:30 |
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Basic information
Public title
Identification of effective morphine administration route for postoperative pain in robot-assisted rectal resection
(prospective intervention, open label test)
Acronym
Identification of effective morphine administration route for robot-assisted rectal resection
Scientific Title
Identification of effective morphine administration route for postoperative pain in robot-assisted rectal resection
(prospective intervention, open label test)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111(35680)
niiyama@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukitoshi Niiyama |
Organization
Sapporo Medical University, School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL
011-611-2111(35680)
Homepage URL
niiyama@sapmed.acjp
Sponsor or person
Institute
Sapporo Medical University School of Medicine Clinical Department
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040009
