UMIN-CTR Clinical Trial

Public title

Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty

Acronym

Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty

Scientific Title

Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty

Scientific Title:Acronym

Study of effectiveness of acetaminophen for the postoperative pain after total hip arthroplasty

Region

Japan

Condition

hip osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Shiniti Yoshiya

Organization

Hyogo college of medicine

Division name

Department of Orthropaedic Surgery

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya-city, Hyogo

TEL

0798456452

Email

secret@hyo-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Maiko Koike

Organization

Hyogo college of medicine

Division name

Department of Orthropaedic Surgery

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya-city, Hyogo

TEL

0798456452

Homepage URL

Email

secret@hyo-med.ac.jp

Institute

Hyogo colleage of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫医科大学病院（兵庫県）

Date of disclosure of the study information

2016

Year

06

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

03

Month

29

Day

Date of IRB

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

Other related information

Registered date

2016

Year

06

Month

17

Day

Last modified on

2019

Year

03

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026185