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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032207
Receipt No. 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

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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
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/ctr_e/ctr_view.cgi?recptno=R000036554

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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