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)

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name