UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031198 |
|---|---|
| Receipt number | R000035624 |
| Scientific Title | Predictive value of preoperative inflammation-related factors for postoperative analgesic consumption in patients with inflammatory bowel disease: a retrospective observational study. |
| Date of disclosure of the study information | 2018/02/28 |
| Last modified on | 2022/03/09 21:07:04 |
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Basic information
Public title
Predictive value of preoperative inflammation-related factors for postoperative analgesic consumption in patients with inflammatory bowel disease: a retrospective observational study.
Acronym
Predictive value of preoperative inflammation for postoperative analgesic consumption in IBD patients.
Scientific Title
Predictive value of preoperative inflammation-related factors for postoperative analgesic consumption in patients with inflammatory bowel disease: a retrospective observational study.
Scientific Title:Acronym
Predictive value of preoperative inflammation for postoperative analgesic consumption in IBD patients.
Region
| Japan |
Condition
Condition
Inflammatory Bowel Disease
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the relationship between preoperative inflammation and postoperative consumption of fentanyl given by intravenous patient-controlled analgesia in patients with inflammatory bowel syndrome.
Basic objectives2
Others
Basic objectives -Others
Analgesic consumption.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative consumption of fentanyl given by intravenous patient-controlled analgesia (24, 48, and 72 hours after surgery).
Key secondary outcomes
Postoperative outcomes (complications, recovery, length of stay)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Underwent laparotomy for inflammatory bowel syndrome.
Used intravenous fentanyl for patient-controlled postoperative analgesia.
Have temporal recording of postoperative analgesic consumption.
Have electronic perioperative medical records.
Key exclusion criteria
Hepatic failure
Renal failure
Hematological disease
Unable to use patient-controlled analgesia
Under preoperative influence of narcotics
Unwilling to participate
Defect in medical records
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Tsuboi |
Organization
Yokohama Municipal Citizens' Hospital
Division name
Department of Anesthesia
Zip code
221-0855
Address
1-1 Mitsuzawanishimachi, Kanagawa, Yokohama, Kanagawa
TEL
045-316-4580
stsuboi-cu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Gaku |
| Middle name | |
| Last name | Inagawa |
Organization
Yokohama Municipal Citizens' Hospital
Division name
Department of Anesthesia
Zip code
221-0855
Address
1-1 Mitsuzawanishimachi, Kanagawa, Yokohama, Kanagawa
TEL
045-316-4580
Homepage URL
yokohama.city.anesth@gmail.com
Sponsor or person
Institute
Department of Anesthesia,
Yokohama Municipal Citizens' Hospital
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
Yokohama Municipal Citizens' Hospital IRB
Address
1-1 Mitsuzawanishimachi, Kanagawa, Yokohama, Kanagawa, 221-0855
Tel
045-316-4580
by-sh-kenkyu@city.yokohama.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
横浜市立市民病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 28 | 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
179
Results
Intraoperative fentanyl consumption, current smoking, ulcerative colitis, administration of biologics during the month before surgery, and the use of supplementary analgesics had a significant increasing effect on postoperative fentanyl consumption, whereas droperidol concentration in the PCA solution, age, and diabetes mellitus had a significant decreasing effect. Preoperative use of opioids was a non-significant variable. The adjusted coefficient of determination was 0.302.
Results date posted
| 2022 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age 37.3(SD 13.3)
Male:Female 130(72.6%):49(27.4%)
BMI 18.8(SD 3.06)
Physical status:
ASA 1=3(1.7%), ASA 2=167(93.3%), ASA 3=9(5.0%)
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 02 | Month | 25 | Day |
Other
Other related information
To determine the relationship between preoperative inflammation and postoperative consumption of fentanyl given by intravenous patient-controlled analgesia in patients with inflammatory bowel disease.
Management information
Registered date
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035624
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| Registered date | File name |
| Research case data | |
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