UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024632
Receipt No. 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

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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
Email 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
Email tanini-h@okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028337

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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