UMIN-CTR Clinical Trial

Basic information
Public title	Analgesic Safety of Periodic Intravenous Infusion of Acetaminophen After Hepatectomy
Acronym	Analgesic Safety of Periodic Intravenous Infusion of Acetaminophen After Hepatectomy
Scientific Title	Single-center retrospective observation study by a propensity score matching analysis about analgesic safety of periodic intravenous infusion of acetaminophen after hepatectomy
Scientific Title:Acronym	Examination of the postoperative pain control method with periodic intravenous infusion of acetaminophen after hepatectomy
Region	Japan

Condition
Condition	Hepatectomy without biliary reconstruction
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigation of the analgesic safety of periodic intravenous infusion of acetaminophen following hepatectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigation of the analgesic safety of periodic intravenous infusion of acetaminophen following hepatectomy
Key secondary outcomes	Postoperative liver enzyme concentrations Postoperative complications postoperative hospital stays

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	Patients who underwent hepatectomy without biliary reconstruction at St. Marianna University Hospital since January 2014.
Key exclusion criteria	Patients who suffered postoperative infectious complication and/or postoperative bleeding.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Katayama
Organization	St. Marianna University School of Medicine
Division name	Division of Gastroenterological and General Surgery
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL	+81-44-977-8111
Email	masafumi@marianna-u.ac.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Katayama
Organization	St. Marianna University School of Medicine
Division name	Division of Gastroenterological and General Surgery
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
TEL	+81-44-977-8111
Homepage URL
Email	masafumi@marianna-u.ac.jp

Sponsor
Institute	Division of Gastroenterological and General Surgery, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	None
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	Institutional Review Board of St. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
Tel	+81-44-977-8111
Email	k-sienbu.mail@marianna-u.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	聖マリアンナ医科大学病院（神奈川県）　St. Marianna University Hospital, Kanagawa

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	DOI: 10.33425/2639-9334.1038
Number of participants that the trial has enrolled	92
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2019 Year 12 Month 22 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 10 Month 01 Day
Date of IRB	2019 Year 10 Month 31 Day
Anticipated trial start date	2019 Year 11 Month 18 Day
Last follow-up date	2019 Year 11 Month 29 Day
Date of closure to data entry	2019 Year 11 Month 29 Day
Date trial data considered complete	2019 Year 11 Month 29 Day
Date analysis concluded	2019 Year 11 Month 29 Day

Other

Other related information

The study included the patients who had undergone hepatectomy without biliary reconstruction at St. Marianna University Hospital since January 2014. These patients were identified from among a larger group of patients, and propensity score matching allowed for the creation of two study groups: the patients who had undergone periodic intravenous infusion of acetaminophen for postoperative pain management, and the control patients who had undergone bolus injections of the non-steroidal anti-inflammatory drug upon request. The two groups were compared retrospectively in terms of clinical characteristics; operative variables; details regarding postoperative analgesia; concentrations of serum liver enzymes and in-hospital outcomes and complications.

Management information
Registered date	2019 Year 11 Month 16 Day
Last modified on	2020 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043992