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
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
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
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
