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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010995
Receipt No. R000012787
Scientific Title Prospective Observational Study of Postoperative Opioid Consumption in Chronic Opioid-Cunsuming Patients
Date of disclosure of the study information 2013/06/20
Last modified on 2019/08/30

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Basic information
Public title Prospective Observational Study of Postoperative Opioid Consumption in Chronic Opioid-Cunsuming Patients
Acronym Prospective Observational Study of Postoperative Opioid Consumption in Chronic Opioid-Cunsuming Patients
Scientific Title Prospective Observational Study of Postoperative Opioid Consumption in Chronic Opioid-Cunsuming Patients
Scientific Title:Acronym Prospective Observational Study of Postoperative Opioid Consumption in Chronic Opioid-Cunsuming Patients
Region
Japan

Condition
Condition Chronic opioid-consuming patients suffering from cancer pain or chronic pain who schedule a surgery
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Pediatrics
Dermatology Oto-rhino-laryngology Orthopedics
Urology Anesthesiology Oral surgery
Neurosurgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We research prospectively about how many amount of morphine chronic opioid-consuming patients require after surgery.
Many patients suffering from cancer pain or chronic pain use opioids and some of them undergo surgery as same as the other opioid-free patients. In usual, we optimize amount of opioid for postoperative pain considering of patient's data, for example, age, weight, and location and size of wound. Although it is enough for opioid-free patients, we have no idea about how many amount of opioid chronic opioid-consuming patients require so far.
According to the retrospective study we reported (journal of japanese pain clinic society.2012;19(3):436), they required more amount of opioid in 24 hours after surgery than before, regardless of epidural anesthesia and removal of suffering part. However, I have not got enough assessment about complications, for example nausea, somnolence and respiratory depression, in the retrospective study. We research also complications and score of numerical rating scale for estimation of pain relief.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes amount of morphine that chronic opioid-consuming patients require within 24 hours after surgery
Key secondary outcomes complications such like nausea, somnolence and respiratory depression and score of numerical rating scale

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Chronic opioid-consuming patients who are suffering from cancer pain or chronic pain and use patient-controlled analgesia after surgery.

We retrospectively identified key factors to predict postoperative opioid requirement in chronic opioid-consuming patients who underwent elective surgeries
Key exclusion criteria taking buprenorphine,
with impairment of consciousness,
under sedation after sugery,
with renal dysfunction,
with symptom of ileus,
morphine allergy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Saori Hashiguchi
Organization Keio University
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo Japan 1608582
TEL 03-3353-1211ext.61608
Email saori-h@z3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naho Ihara
Organization Keio University
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo Japan 1608582
TEL 03-3353-1211ext.61608
Homepage URL
Email naho.loves.shiho@gmail.com

Sponsor
Institute Department of Anesthesiology, Keio University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 慶応義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 20 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 Completed
Date of protocol fixation
2013 Year 06 Month 01 Day
Date of IRB
2013 Year 05 Month 27 Day
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2019 Year 08 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational study
retrospective observational study

Management information
Registered date
2013 Year 06 Month 18 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012787

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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