UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008949 |
|---|---|
| Receipt number | R000010493 |
| Scientific Title | Analgesic effect of the continuous bilateral transversus abdominis plane block using levobupivacaine after gynecological laparotomy; continuous block versus single-injection block.A double-blind trial. |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2013/08/09 13:01:07 |
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Basic information
Public title
Analgesic effect of the continuous bilateral transversus abdominis plane block using levobupivacaine after gynecological laparotomy; continuous block versus single-injection block.A double-blind trial.
Acronym
Analgesic effect of the continuous bilateral transversus abdominis plane block using levobupivacaine after gynecological laparotomy; continuous block versus single-injection block.A double-blind trial.
Scientific Title
Analgesic effect of the continuous bilateral transversus abdominis plane block using levobupivacaine after gynecological laparotomy; continuous block versus single-injection block.A double-blind trial.
Scientific Title:Acronym
Analgesic effect of the continuous bilateral transversus abdominis plane block using levobupivacaine after gynecological laparotomy; continuous block versus single-injection block.A double-blind trial.
Region
| Japan |
Condition
Condition
Patients who are scheduled for laparotomy in gynecologic cancer and may have pelvic lymph node biopsy or dissection.
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will test the hypothesis that the continuous bilateral transversus abdominis plane block may decrease postoperative pain compared with single-injection block after laparotomy in gynecologic cancer patient who receive perioperative anticoagulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale (VAS) pain scores at rest and at mobilization after 6,15 and 24hours postoperation.
Key secondary outcomes
1.Incidence of nausea and vomitting
2.Incidence of drousiness
3.Postoperative fentanyl consumption
4.Additional analgesics
5.Ocurrence of local anesthetic intoxication
6.Effect site concentration of fentanyl at the discharge from operating room and at the visit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Patients will receive ultrasound-guided transversus abdominis plane block.They will receive analgesia through a catheter placed into transversus abdominis plane and connected to levobupivacaine infusion after surgery.
Interventions/Control_2
Patients will receive ultrasound-guided transversus abdominis plane block by levobupivacaine single-injection.
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Patients who are scheduled for laparotomy in gynecologic cancer and may have pelvic lymph node biopsy or dissection in Osaka University Hospital
2.Patients who receive subcutaneous heparin for prophylaxis of deep venous thrombosis and cannot receive epidural anesthesia
3. Patients who can give written informed consent
Key exclusion criteria
1.Patinets who have risk factor in American Society of Anesthesiologists physical status over 3
2.Patinets who are allergic to local anesthetics
3.Pantients who have abdominal pain before surgery or use analgetic drugs for chronic pain
4.Patients who have severe paralysis or severe neurologic disease
5.Patients who are regarded ineligible by doctors with any other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Carl Shibata |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
E7-2-2, Yamadaoka, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Carl Shibata |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
E7-2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3313
Homepage URL
Sponsor or person
Institute
Osaka 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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 19 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 20 | Day |
Last modified on
| 2013 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010493
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