UMIN-CTR Clinical Trial

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
Email	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
Email	yokohama.city.anesth@gmail.com

Sponsor
Institute	Department of Anesthesia, Yokohama Municipal Citizens' Hospital
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	Yokohama Municipal Citizens' Hospital IRB
Address	1-1 Mitsuzawanishimachi, Kanagawa, Yokohama, Kanagawa, 221-0855
Tel	045-316-4580
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035624