UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effect of Nefopam on Postoperative Fentanyl Consumption: A Randomized, Double-blind Study
Title of the study (Brief title)	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	Sang sik Choi
Organization	Korea University Guro Hospital
Division name	Department of Anesthesiology and Pain medicine
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	Jung eun Kim
Organization	Korea University Guro Hospital
Division name	Department of Anesthesiology and Pain medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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