UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062885 |
|---|---|
| Receipt number | R000072006 |
| Scientific Title | Postoperative pain management and associated factors in patients with preoperative opioid use: a retrospective cohort study |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 16:51:12 |
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Basic information
Public title
Postoperative pain management and associated factors in patients with preoperative opioid use: a retrospective cohort study
Acronym
Postoperative Pain in Preoperative Opioid Users
Scientific Title
Postoperative pain management and associated factors in patients with preoperative opioid use: a retrospective cohort study
Scientific Title:Acronym
Postoperative Pain in Preoperative Opioid Users
Region
| Japan |
Condition
Condition
chronic pain, cancer pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Postoperative pain management in chronic opioid users is challenging due to the narrow therapeutic window caused by opioid tolerance, opioid-induced hyperalgesia, and withdrawal risks. Although we implemented a protocol based on our previous institutional evidence, diversifying patient backgrounds and psychosocial factors now complicate care. This retrospective study aims to comprehensively evaluate the actual status of postoperative pain management and identify factors associated with inadequate pain control in preoperative opioid users, thereby improving perioperative management strategies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS pain score at 24 hours postoperatively
Key secondary outcomes
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
Adult patients who underwent general anesthesia at our hospital and were using opioids prior to surgery.
Key exclusion criteria
Individuals who have requested not to participate in this study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Naho |
| Middle name | |
| Last name | Ihara |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
03-3353-1211
naho.ihara@keio.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Ihara |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
naho.ihara@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio 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
Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
| 2026 | Year | 09 | Month | 11 | 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
| 2026 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single center retrospective cohort study. Perioperative data including baseline characteristics, preoperative opioid doses, 24 hour postoperative Numerical Rating Scale pain scores, opioid consumption, and adverse events will be extracted from electronic medical records for patients with preoperative opioid use who underwent surgery. The primary outcome is the NRS pain score at 24 hours postoperatively. Subgroup and logistic regression analyses will be performed to identify associated factors.
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072006
