UMIN-CTR Clinical Trial

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
Last 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
1st 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
Institute	Nagasaki Rosai Hospital Medical Office
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036554