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Recruitment status Completed
Unique ID issued by UMIN UMIN000009001
Receipt No. R000010557
Scientific Title Addition of epinephrine spoils anti-pruritic effect of butorphanol against epidural morphine
Date of disclosure of the study information 2012/09/28
Last modified on 2012/09/28

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Basic information
Public title Addition of epinephrine spoils anti-pruritic effect of butorphanol against epidural morphine
Acronym Co-use of epinephrine and butorphanol
Scientific Title Addition of epinephrine spoils anti-pruritic effect of butorphanol against epidural morphine
Scientific Title:Acronym Co-use of epinephrine and butorphanol
Region
Japan

Condition
Condition gynecological open surgery; abdominal-hysterectomy, hysterosalpingo-oophorectomy, and salpingo-oophorectomy
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study was aimed to elucidate the hypothesis that co-use of epinephrine with anti-pruritic drug should afford further reduction of pruritus associated with epidural morphine after gynecological open surgeries.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes Primary endpoint was the incidence of pruritus during the postoperative 24 hours.
Key secondary outcomes The following measures were selected at the secondary endpoint: incidences of dizziness, incidences of postoperative emesis (none, nausea, retching, and vomiting), intensities of postoperative wound pain: Visual analogue scales (VAS, mm: 0 = no pain, 100 = worst pain imaginable, at rest and at coughing), and incidences of side effects.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 control group was set as patients who received postoperative epidural infusion (2ml/hour) of 0.2% ropivacaine 100ml containing morphine 6 mg and butorphanol 2 mg with no epinephrine.
Interventions/Control_2 E0.15 group was set as patients who received postoperative epidural infusion (2ml/hour) of 0.2% ropivacaine 100ml containing morphine 6 mg and butorphanol 2 mg with 0.15 mg epinephrine.
Interventions/Control_3 E0.3 group was set as patients who received postoperative epidural infusion (2ml/hour) of 0.2% ropivacaine 100ml containing morphine 6 mg and butorphanol 2 mg with 0.3 mg epinephrine.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria ASA physical status 1-2
Key exclusion criteria Patients were excluded from the study if one or more of the following criteria were met: allergy to opioids, concurrent use of antidepressants or analgesics, smoking habit, medical histories of chronic inflammatory disease and motion sickness, severe obesity (BMI > 25), contraindications to epidural catheterization such as infection, anatomical abnormalities of the spine, or full anticoagulation.
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Kawashima
Organization Wakayama Medical University
Division name Department of Anesthesiology
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Wakayama Medical University
Division name Department of Anesthesiology
Zip code
Address 811-1 Kimiidera, Wakayama City, Wakayama 641-8509, Japan
TEL 073-447-2300
Homepage URL
Email whisky_finger@yahoo.co.jp

Sponsor
Institute Japanese Red Cross Society Wakayama Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
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 日本赤十字社和歌山医療センター(和歌山県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 28 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
The incidence of pruritus in E0.3 (35.5 %) was significantly higher compared with E0.15 (9.7 %). The incidence of dizziness in control (16.1 %) was significantly lower compared with E0.15 (48.4 %, p=0.013) or E0.3 (45.2 %, p=0.026). Other data did not differ significantly among the groups. (2008 ASA Annual Meeting in Orlando)
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
2007 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 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
2012 Year 09 Month 28 Day
Last modified on
2012 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010557


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