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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016540
Receipt No. 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

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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
Email 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
Email geri200@gmail.com

Sponsor
Institute Korea University Guro Hospital, Department of Anesthesiology and Pain medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019201

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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