UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019766 |
|---|---|
| Receipt number | R000022828 |
| Scientific Title | Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial. |
| Date of disclosure of the study information | 2015/11/12 |
| Last modified on | 2015/11/12 16:49:22 |
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Basic information
Public title
Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.
Acronym
Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.
Scientific Title
Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.
Scientific Title:Acronym
Analgesic effect of peripheral nerve block after gynecological lower abdominal surgery; concentration versus volume of local anesthetic.A prospective randomized trial.
Region
| Japan |
Condition
Condition
Patients who are scheduled for gynecological lower abdominal surgery.
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will compared low concentration-high volume ropivacaine with high concentration-low volume ropivacaine using for transversus abdominis plane block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative morphine consumption after 4, 24, 48, and 72 hours.Using patient controlled analgesia.
Key secondary outcomes
Pain:Visual analogue scale(VAS) at rest and at cough after 4, 24, 48, and 72 hours postoperation.
Adverse event.
Blood pressure and SpOs after 4,24,48 and 72 hours postoperation,
Ropivacaine plasma concentration after 0,15,30,45,60 and 120 mins after transversus abdominis plane block.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Patinets will receive ultrasound-guided transversus abdominis plane block using 0.4%,3 mg/kg of ropivacaine.
Interventions/Control_2
Patinets will receive ultrasound-guided transversus abdominis plane block using 0.2%,3 mg/kg of ropivacaine.
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Patients who are scheduled for gynecological lower abdominal surgery in Nagoya university hospital.
2)American Society of Anethesiologists physical status in 1, 2 or 3.
3)Patients who can evaluate the pain using visual analogue scale(VAS)
4)Patients who can give written informed consent,
Key exclusion criteria
1)Patients who have stomach ulcer, renal failure or liver failure.
2)Patients who have allergy to the drugs which will going to use in this trial.
3)Patients who have severe obesity over BMI 30.
4)Patients who have contraindication of Ropivacaine.
5)Patients who are regarded ineligible by doctors with ather reasons.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitoshi Nishiwaki |
Organization
Nagoya University Hospital
Division name
Department of Anesthesiology
Zip code
Address
65, Thurumai town, Showa ward, Nagoya-city, Aichi
TEL
052-744-2340
a-ohashi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Akane |
Organization
Nagoya University Hospital
Division name
Department of Anethesiology
Zip code
Address
65, Thurumai town, Showa ward, Nagoya city, Aichi
TEL
052-744-2340
Homepage URL
a-ohashi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
名古屋大学医学部付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 12 | 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
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
| 2011 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 12 | Day |
Last modified on
| 2015 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022828
