UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013884
Receipt No. R000013913
Scientific Title Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Date of disclosure of the study information 2014/05/03
Last modified on 2017/05/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Acronym Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Scientific Title Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Scientific Title:Acronym Study of prophylactic effect of pentazocine on spinal morphine-induced pruritus and PONV
Region
Japan

Condition
Condition womem schedulled for cesarean section using combined spinal-epidural anesthesia
Classification by specialty
Obsterics and gynecology Anesthesiology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate pentazocine in patients subject to cesarean section for the prophylactic effect on the postoperative pruritus, nausea and vomiting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes postoperative pain, postoperative pruritus, PONV,
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 pentazocin 15mg iv
Interventions/Control_2 normal saline 1ml iv
Interventions/Control_3
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
45 years-old >=
Gender Female
Key inclusion criteria ASA1-2 patients undergoing elective cesarean section using combined spinal-epidural anesthesia
Key exclusion criteria emergency cases, ASA PS more than 3, coagulation disorder
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsushi Doi
Organization Hamada Medical Center
Division name Anesthesiology
Zip code
Address 777-12 Asai-cho, Hamada, Shimane
TEL 0855-25-0505
Email kdoiepi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Katsushi Doi
Organization Hamada Medical Center
Division name Anesthesiology
Zip code
Address 777-12 Asai-cho, Hamada, Shimane
TEL 0855-25-0505
Homepage URL
Email kdoiepi@gmail.com

Sponsor
Institute Hamada Medical Center Department of Anesthesiology
Institute
Department

Funding Source
Organization Hamada Medical Center Department of Anesthesiology
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
2014 Year 05 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2015 Year 09 Month 30 Day
Date of closure to data entry
2015 Year 12 Month 10 Day
Date trial data considered complete
2015 Year 12 Month 15 Day
Date analysis concluded
2017 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 03 Day
Last modified on
2017 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013913

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.