UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty
Title of the study (Brief title)	Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty
Region	Japan

Condition
Condition	hip osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Previous study reported, nerve blocks were effective in the perioperative pain after total hip arthroplasty. We performed one-hundred cases at our hospital a year. We used fentanyl intravenous injection and femoral nerve block for post-operative pain. These treatments were effective but patients developed mild or moderate pain yet. When the patients were caused sever post-operative pain, we usually used Non-Steroidal Anti-Inflammatory Drugs. These drugs were difficult for renal dysfunction patients or gastric ulcer patients to use. In this study, we used acetaminophen intravenous injection for postoperative pain within 24 hours and we evaluated condition of the improvement of this pain. If we proved usefulness of acetaminophen intravenous injection, we will be able to use for postoperative pain control as one of choice in comparison with NSAIDs.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Pre-operative assessment Numerical Rating Scale (NRS) value. Post-operative assessment NRS (0 hour, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours)
Key secondary outcomes	Patient Controlled Analgesia used amount Opioid consumption volume of 24 hours Postoperative liver function evaluation during 2weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	From date of approval march 2016 to 31 march 2018. All patients were performed total hip arthroplasty. A : 50 patients used acetaminophen intravenous All patients were randomly selected. Acetaminophen was gave medication 4 times to patients within 24 hours. All patients were used femoral nerve block and intravenous fentanyl.
Interventions/Control_2	From date of approval march 2016 to 31 march 2018. All patients were performed total hip arthroplasty. B : 50 patients unused acetaminophen intravenous All patients were randomly selected. All patients were used femoral nerve block and intravenous fentanyl.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The patient who received the primary total hip arthroplasty which was not included in exclusion criteria.
Key exclusion criteria	Patients have a liver function disorder, a renal function disorder. In disease severity of the liver function, we exclude the cases more than grade 2 or class B from the object of this study with "pharmaceutical products side effect serious degree classification" "Child-Pugh classification". In disease severity of the renal function, we excluded the case of Ccr<59. Cases with a history of the past of hypersensitivity. The cases that has difficulty in mutual understanding in self.
Target sample size	100

Research contact person
Name of lead principal investigator	Shiniti Yoshiya
Organization	Hyogo college of medicine
Division name	Department of Orthropaedic Surgery
Address	1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
TEL	0798456452
Email	secret@hyo-med.ac.jp

Public contact
Name of contact person	Maiko Koike
Organization	Hyogo college of medicine
Division name	Department of Orthropaedic Surgery
Address	1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
TEL	0798456452
Homepage URL
Email	secret@hyo-med.ac.jp

Sponsor
Institute	Hyogo colleage of Medicine
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)

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	兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 29 Day
Anticipated trial start date	2016 Year 03 Month 29 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 17 Day
Last modified on	2019 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026185