UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010995 |
|---|---|
| Receipt number | 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 18:56:45 |
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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 | Obstetrics 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
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
naho.loves.shiho@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012787
