UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016540 |
|---|---|
| Receipt number | R000019201 |
| Scientific Title | The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study |
| Date of disclosure of the study information | 2015/02/28 |
| Last modified on | 2017/08/02 11:16:29 |
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Basic information
Public title
The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study
Acronym
Nefopam Spares Fentanyl Consumption
Scientific Title
The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study
Scientific Title:Acronym
Nefopam Spares Fentanyl Consumption
Region
| Asia(except Japan) |
Condition
Condition
laparoscopic total hysterectomy patients under general anesthesia
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether The concomitant use of opioids and nefopam is is effective for postoperative pain management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total fentanyl consumption during 48h
Key secondary outcomes
1.relief of VPS(verbal pain score) and NRS (numerical rating scale) score
2.incidence of side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.Fentanyl 1000gm in total volume 100mL PCA to be administered over the first 48 h postoperatively
Interventions/Control_2
Fentanyl 500gm + Nefopam (NFP) 200 mg in total volume 100mL PCA to be administered over the first 48 h postoperatively
Interventions/Control_3
3)Fentanyl 500gm + Nefopam (NFP) 400 mg in total volume 100mL PCA to be administered over the first 48 h postoperatively
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1)American Society of Anesthesiologists (ASA) physical status class I, II
2) patients were scheduled for laparoscopic total hysterectomy under general anesthesia
Key exclusion criteria
1)ASA physical status class III, IV
2)BMI> 35
3)history of drug abuse or suspected drug abuse
4)history of illegal drug use or drug dependence
5)history of chronic pain disease
6)known intolerance of or hypersensitivity to nefopam
7)those who have or had conditions with a possible risk of affecting the interpretation of the study results, safety, and subject participation including cancer, neurologic, psychologic, cardiac, hepatic, hematologic, muscular, dermatologic, genital problems, or were in an immunocompromised state
8) others who the investigator judged to be inappropriate candidates for participation in the clinical study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sang sik Choi |
Organization
Korea University Guro Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
Address
Korea University Guro Hospital, Guro 2-dong, Guro-gu, Seoul, Republic of Korea 152-703
TEL
82-10-8270-3725
clonidine@empal.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jung eun Kim |
Organization
Korea University Guro Hospital
Division name
Department of Anesthesiology and Pain medicine
Zip code
Address
Korea University Guro Hospital, Guro 2-dong, Guro-gu, Seoul, Republic of Korea 152-703
TEL
82-10-7271-5391
Homepage URL
geri200@gmail.com
Sponsor or person
Institute
Korea University Guro Hospital, Department of Anesthesiology and Pain medicine
Institute
Department
Personal name
Funding Source
Organization
Korea University Guro Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 02 | Month | 28 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 14 | 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
| 2015 | Year | 02 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019201
