UMIN-CTR Clinical Trial

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
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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
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IRB Contact (For public release)
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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
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Results Delayed
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Baseline Characteristics
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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/icdr_e/ctr_view.cgi?recptno=R000012787