UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013319 |
|---|---|
| Receipt number | R000015541 |
| Scientific Title | Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients. |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2021/09/24 17:17:48 |
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Basic information
Public title
Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Acronym
Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Scientific Title
Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Scientific Title:Acronym
Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Region
| Japan |
Condition
Condition
Patients who are scheduled for renal transplant from living donor
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will test the hypothesis that the continuous transversus abdominis plane block may decrease postoperative pain compared with conventional multimodal analgesia including IVPCA fentanyl for renal transplant recipients who may receive perioperative anticoagulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative fentanyl consumption in 48hours postoperation
Key secondary outcomes
1. Visual Analogue Scale (VAS) pain scores at rest and at mobilization after 4, 16, 24, 40 and 48hours postoperation.
2. Incidence of nausea and vomitting
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) 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 a standardized general anesthetic with multimodal analgesia including IV-PCA fentanyl and ultrasound-guided transversus abdominis plane block. They will receive analgesia through a catheter placed into transversus abdominis plane and connected to levobupivacaine infusion postoperatively.
Interventions/Control_2
Patients will receive a standardized general anesthetic with conventional multimodal analgesia including IV-PCA fentanyl. They will not receive transversus abdominis plane block.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are scheduled for renal transplant from living donor in Osaka University Hospital
2. Patients who may receive anticoagulantion and cannot receive epidural anesthesia
3. Patients who can give written informed consent
Key exclusion criteria
1. Patinets who are allergic to any medication used in the study
2. Pantients who have abdominal pain before surgery or use analgetic drugs for chronic pain
3. Patients who have severe paralysis or severe neurologic disease
4. Patients who are regarded ineligible by doctors with any other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | Carl |
| Last name | Shibata |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
E7-2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3133
karlshibata@pain.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Maeda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
565-0871
Address
E7-2-2, Yamadaoka, Suita, Osaka
TEL
06-6879-3133
Homepage URL
amaeda@anes.med.osaka-u.ac.jp
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
Medical Center for Translational Research Osaka University Hospital
Address
2-15, Yamadaoka, Suita, Osaka
Tel
06-6879-6090
shiken@hp.crc.osaka-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
| 2014 | Year | 03 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015541
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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