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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027226
Receipt No. R000031193
Scientific Title Antipruritic effect of prophylactic pentazocine combined with ultra-low-dose naloxone on intrathecal opioids-induced pruritus after cesarean delivery: a double-center prospective, controlled trial
Date of disclosure of the study information 2017/05/08
Last modified on 2019/04/05

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Basic information
Public title Antipruritic effect of prophylactic pentazocine combined with ultra-low-dose naloxone on intrathecal opioids-induced pruritus after cesarean delivery: a double-center prospective, controlled trial
Acronym Antipruritic effect of pentazocine combined with ultra-low-dose naloxone on opioids-induced pruritus
Scientific Title Antipruritic effect of prophylactic pentazocine combined with ultra-low-dose naloxone on intrathecal opioids-induced pruritus after cesarean delivery: a double-center prospective, controlled trial
Scientific Title:Acronym Antipruritic effect of pentazocine combined with ultra-low-dose naloxone on opioids-induced pruritus
Region
Japan

Condition
Condition Opioids-induced pruritus
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This randomized prospective, controlled trial aimed to evaluate the effect of intraoperative IV pentazocine combined with ultra-low-dose naloxone on the incidence of opioid-induced pruritus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the incidence of opioid-induced pruritus within the first 24 hr after administration of opioids.
Key secondary outcomes

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 After delivery of the baby, the parturient women were randomized to intravenously receive 15 mg of pentazocine + ultra-low-dose Naloxone.
Interventions/Control_2 After delivery of the baby, the parturient women were randomized to intravenously receive 15 mg of pentazocine + saline.
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
50 years-old >=
Gender Female
Key inclusion criteria ASA physical status 2-3 patients who presented for elective cesarean delivery under spinal anesthesia were included in this study.
written informed consent was obtained from each patient enrolled in the study.
Key exclusion criteria 1) Emergency cesarean delivery
2) Allergy to pentazocine, naloxone, morphine, fentanyl, bupivacaine, or levobupivacaine
3) Preexisting pruritus
4)Patient with preeclampsia,diabetes mellitus; or neurologic disease.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Noritaka
Middle name
Last name Imamachi
Organization Shimane University Faculty of Medicine
Division name Department of Anesthesiology
Zip code 6938501
Address 89-1 Enyacho Izumo, Shimane, Japan
TEL 0853-20-2295
Email imamachi@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Noritaka
Middle name
Last name Imamachi
Organization Shimane University Faculty of Medicine
Division name Department of Anesthesiology
Zip code 6938501
Address 89-1 Enyacho Izumo, Shimane, Japan
TEL 0853-20-2295
Homepage URL
Email imamachi@med.shimane-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Anesthesiology, Hamada Medical Center
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Clinical Research Center, University Hospital, Shimane University Faculty of Medicine
Address 89-1 Enyacho Izumo, Shimane, Japan
Tel 0853-20-2259
Email kenkyu@med.shimane-u.ac.jp

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
2017 Year 05 Month 08 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 101
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
2017 Year 04 Month 24 Day
Date of IRB
2017 Year 04 Month 24 Day
Anticipated trial start date
2017 Year 05 Month 09 Day
Last follow-up date
2019 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 02 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031193

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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