UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032207
Receipt number R000036554
Scientific Title Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil after lumbar disc surgery
Date of disclosure of the study information 2018/04/16
Last modified on 2019/03/26 11:02:43

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Basic information

Public title

Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil after lumbar disc surgery

Acronym

Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil after lumbar disc surgery

Scientific Title

Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil after lumbar disc surgery

Scientific Title:Acronym

Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil after lumbar disc surgery

Region

Japan


Condition

Condition

lumbar disc surgery

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Postoperative pain control is important after lumbar disc surgery. Because postoperative pain is the result of activation of different pain mechanisms, including nociceptive, neuropathic and inflammatory pains, multimodal analgesic are generally used. Although opioid, especially fentanyl, based analgesia is a well-established therapy for postoperative pain control, opioids increase the incidence of PONV and respiratory depression. Acetaminophen and nonsteroidal anti-inflammatory drugs were reported to reduce opioid consumption and opioid related side effects after lumbar disc surgery. However, there are few reports compared postoperative analgesic effects between flurbiprofen and acetaminophen after lumbar disc surgery. This prospective, randomized, open-label and placebo controlled study aimed to determine whether whether flurbiprofen produces equivalent analgesic effects to acetaminophen after lumbar disc surgery.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The pain score was evaluated by numeric rating scale (NRS) from 0 to 10 at 0, 1, 3, 6, 12, 18, 24 hours postoperatively

Key secondary outcomes

Frequency of rescue rescue analgesics administration during 12hs, 24hs, postoperatively


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

All patients were anesthetized under total intravenous anesthesia with propofol and remifentanil according to clinical requirement. All patients received bolus administration of 0.15mg fentanyl 30 min before the end of surgery and 0.1mg fentanyl at skin closure. Group P received 10mL of saline intravenously at end of surgery, and 6, 12, and 18 hrs postoperatively Postoperative pain was evaluated by nursing staffs using a numerical rating scale (NRS) at 0, 1, 3, 6, 12, 18, 24h postoperatively. Frequency of use of rescue analgesics and consumption of rescue analgesics were recorded for 12 and 24h after surgery.

Interventions/Control_2

All patients were anesthetized under total intravenous anesthesia with propofol and remifentanil according to clinical requirement. All patients received bolus administration of 0.15mg fentanyl 30 min before the end of surgery and 0.1mg fentanyl at skin closure. Group A received 1000mg of acetaminophen intravenously at end of surgery, and 6, 12, and 18 hr postoperatively. Postoperative pain was evaluated by nursing staffs using a numerical rating scale (NRS) at 0, 1, 3, 6, 12, 18, 24h postoperatively. Frequency of use of rescue analgesics and consumption of rescue analgesics was recorded for 12 and 24h after surgery.

Interventions/Control_3

All patients were anesthetized under total intravenous anesthesia with propofol and remifentanil according to clinical requirement. All patients received bolus administration of 0.15mg fentanyl 30 min before the end of surgery and 0.1mg fentanyl at skin closure. Group A received 50mg of flurbiprofen intravenously at end of surgery, and 6, 12, and 18 hr postoperatively. Postoperative pain was evaluated by nursing staffs using a numerical rating scale (NRS) at 0, 1, 3, 6, 12, 18, 24h postoperatively. Frequency of use of rescue analgesics and consumption of rescue analgesics was recorded for 12 and 24h after surgery.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

The patients weighting 50-70kg who undergo elective lumbar spine surgery with ASA risk 1 or 2

Key exclusion criteria

1)renal disease
2)liver disease
3)ulcer
4)asthma

Target sample size

75


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Terao

Organization

Nagasaki Rosai Hospital

Division name

Department of anesthesia

Zip code


Address

2-12-5, Setogoe, Sasebo, Nagasaki, Japan

TEL

0956-49-2191

Email

yoterao@na-robyo.jp


Public contact

Name of contact person

1st name
Middle name
Last name Maki Ohno

Organization

Nagasaki Rosai Hospital

Division name

Department of anesthesia

Zip code


Address

2-12-5, Setogoe, Sasebo, Nagasaki, Japan

TEL

0956-49-2191

Homepage URL


Email

blaandjas@gmail.com


Sponsor or person

Institute

Nagasaki Rosai Hospital Medical Office

Institute

Department

Personal name



Funding Source

Organization

The Japan Labon Health and Welfare Organization

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 16 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


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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 12 Day

Last modified on

2019 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036554


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name