UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027226 |
|---|---|
| Receipt number | 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 11:09:35 |
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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
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
imamachi@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031193
