UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008697 |
|---|---|
| Receipt number | R000010223 |
| Scientific Title | Analgesic effect and plasma ropivacaine concentrations after ultrasound-guided peripheral nerve block and postoperative continuous wound infusion in patients undergoing gynecological laparotomy |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2013/10/15 20:22:50 |
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Basic information
Public title
Analgesic effect and plasma ropivacaine concentrations after ultrasound-guided peripheral nerve block and postoperative continuous wound infusion in patients undergoing gynecological laparotomy
Acronym
Analgesic effect and plasma ropivacaine concentrations after ultrasound-guided peripheral nerve block and postoperative continuous wound infusion in patients undergoing gynecological laparotomy
Scientific Title
Analgesic effect and plasma ropivacaine concentrations after ultrasound-guided peripheral nerve block and postoperative continuous wound infusion in patients undergoing gynecological laparotomy
Scientific Title:Acronym
Analgesic effect and plasma ropivacaine concentrations after ultrasound-guided peripheral nerve block and postoperative continuous wound infusion in patients undergoing gynecological laparotomy
Region
| Japan |
Condition
Condition
patients scheduled for gynecological laparotomy under general anesthesia
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the analgesic effect of postoperative continious wound infusion following peripheral nerve block,and examine the safty by measuring plasma ropivacaine concentarations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale (VAS) at rest and at mobilization, assessed at 3, 24,48 and 72hours after surgery
Key secondary outcomes
1.Plasma ropivacaine concentarations before and 16, 40 and 64hours after starting continuous wound infusion
2.Time to independent ambulations
3.Consumption of rescue analgesia at 24,48,72hours after surgery
4.Incidence of nausea and vomitting
5.Ocurrence of local anesthetic intoxication by ropivacaine
6.Ocurrence of adverse effects by cathters placed into the wound
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Patients will receive ultrasound-guided peripheral nerve block
with 0.3mg/kg of ropivacaine diluted 60ml under general anesthesia and laparotomy will be performed.They will receive analgesia through a multi orificce
wound catheter placed below the fascia and connected to ropivacaine
infusion(12mg/kg/50hours) after surgery.
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.female patients(American Society of Anesthesiologists physical status 1 to 3) undergoing gynecologic laparotomy at Sumitomo hospital
2.Written informed consent is provided
Key exclusion criteria
1.over ASA-PS4
2.epidural anesthesia
3.laparoscopic surgery
4.allergy in ropivacaine
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ai Nakamoto |
Organization
Sumitomo Hospital
Division name
Department of Anesthesia
Zip code
Address
5-3-20 Nakanoshima, Kita-ku, Osaka, 530-0005, Japan
TEL
06-6443-1261
nakamoto-ai@sumitomo-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Nakamoto |
Organization
Sumitomo Hospital
Division name
Department of Anesthesia
Zip code
Address
5-3-20 Nakanoshima, Kita-ku, Osaka, 530-0005, Japan
TEL
06-6443-1261
Homepage URL
nakamoto-ai@sumitomo-hp.or.jp
Sponsor or person
Institute
Sumitomo Hospital Department of Anesthesia
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
一般財団法人 住友病院（大阪府）
Sumitomo Hospital (OSAKA)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 15 | 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
| 2012 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 15 | Day |
Last modified on
| 2013 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010223
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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