UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024632 |
|---|---|
| Receipt number | R000028337 |
| Scientific Title | Analgesic effect of additional transverse abdominis plane block with port site infiltration in patients after robot assisted laparoscopic prostatectomy |
| Date of disclosure of the study information | 2016/10/30 |
| Last modified on | 2020/02/29 11:50:43 |
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Basic information
Public title
Analgesic effect of additional transverse abdominis plane block with port site infiltration in patients after robot assisted laparoscopic prostatectomy
Acronym
Effect of additional TAP block with port site infiltration after RALP
Scientific Title
Analgesic effect of additional transverse abdominis plane block with port site infiltration in patients after robot assisted laparoscopic prostatectomy
Scientific Title:Acronym
Effect of additional TAP block with port site infiltration after RALP
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate alagesic effect of additional transverse abdominis plane block (TAP block) with port site infiltration of local anesthetics in patients scheduled robot asststed laparoscopic prostatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain evaluated numerical rating scale (NRS) at immediately, 1h, 4h and 24h after operation
Key secondary outcomes
Intravenous fentanyl dose during first postoperative 24h by using patient controlled method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive 0.375%ropivacaine(15ml on each side) by TAP block before awaking from anethesia. All patients receive port site infiltration with 10ml of 0.2%ropivacaine.
Interventions/Control_2
Patients receive saline(15ml on each side) by TAP block before awaking from anethesia. All patients receive port site infiltration with 10ml of 0.2%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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
All ASA 1-2 patients except for exclusion criteria
Key exclusion criteria
1) ASA 3 or higher
2) Body weight less than 40kg
3) Preoperative opioid use
4) Contraindication with Desflurane
(predisposing malignant hyperthermia, existing neuromuscular disease)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Taninishi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1, Shikata-Cho, Kita-ku, Okayama, Japan
TEL
086-235-7327
tanini-h@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Taninishi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1, Shikata-Cho, Kita-ku, Okayama, Japan
TEL
086-235-7327
Homepage URL
tanini-h@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Tel
086-235-7327
tanini-h@okayama-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
岡山大学病院 （岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-020-60687-y
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-60687-y
Number of participants that the trial has enrolled
108
Results
TAP block by anesthesiologists of varied level of training reduced postoperative pain immediate after RALP. TAP block had fundamental analgesic effect, but this benefit was too small to reduce postoperative 24-hour fentanyl consumption.
Results date posted
| 2020 | Year | 02 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 28 | Day |
Baseline Characteristics
Shown in article, please refer
https://www.nature.com/articles/s41598-020-60687-y
Participant flow
Shown in article, please refer
https://www.nature.com/articles/s41598-020-60687-y
Adverse events
No adverse effects
Outcome measures
Shown in article, please refer
https://www.nature.com/articles/s41598-020-60687-y
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028337
