UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061323 |
|---|---|
| Receipt number | R000070161 |
| Scientific Title | Ultrasound-Guided Bilateral re-M-TAPA Block Versus Surgical Wound Infiltration for Postoperative Analgesia After Robot-Assisted Radical Prostatectomy: A Prospective Randomized Assessor-Blinded Parallel-Group Trial |
| Date of disclosure of the study information | 2026/04/20 |
| Last modified on | 2026/04/20 16:01:48 |
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Basic information
Public title
Comparison of Ultrasound-Guided Bilateral re-M-TAPA Block and Surgical Wound Infiltration for Postoperative Analgesia After Robot-Assisted Radical Prostatectomy
Acronym
re-M-TAPA Prostate Trial
Scientific Title
Ultrasound-Guided Bilateral re-M-TAPA Block Versus Surgical Wound Infiltration for Postoperative Analgesia After Robot-Assisted Radical Prostatectomy: A Prospective Randomized Assessor-Blinded Parallel-Group Trial
Scientific Title:Acronym
re-M-TAPA Prostate RCT
Region
| Japan |
Condition
Condition
Prostate Cancer, Postoperative Pain
Classification by specialty
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of ultrasound-guided bilateral re-M-TAPA block on postoperative analgesia compared with surgical wound infiltration in patients undergoing robot-assisted radical prostatectomy. The primary outcome is cumulative opioid consumption within 24 hours postoperatively, expressed as intravenous morphine milligram equivalents (MME). Secondary outcomes include postoperative pain scores (Numerical Rating Scale) at 2, 6, 12, and 24 hours, incidence of postoperative nausea and vomiting, time to first rescue analgesia, quality of recovery (QoR-15) at 24 hours, and sensory block distribution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative opioid consumption within 24 hours postoperatively, expressed as intravenous morphine milligram equivalents (MME)
Key secondary outcomes
Postoperative pain scores (Numerical Rating Scale) at 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting within 24 hours; time to first rescue analgesia; quality of recovery (QoR-15) at 24 hours; and sensory block distribution
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the intervention group, ultrasound-guided bilateral re-M-TAPA block will be performed after induction of general anesthesia and before the start of surgery. The type, concentration, and volume of local anesthetic will be determined according to the institutional protocol. Perioperative general anesthesia management and postoperative analgesic protocols will be standardized between the two groups.
Interventions/Control_2
In the control group, surgical wound infiltration with local anesthetic will be performed at the end of surgery. The type, concentration, and volume of local anesthetic will be determined according to the institutional protocol. Perioperative general anesthesia management and postoperative analgesic protocols will be standardized between the two groups.
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
| Not applicable |
Gender
Male
Key inclusion criteria
Male patients aged 20 years or older
Scheduled for elective robot-assisted radical prostatectomy
American Society of Anesthesiologists (ASA) physical status 1-3
Provided written informed consent
Key exclusion criteria
History of allergy to local anesthetics
Chronic opioid use prior to surgery
Coagulopathy or ongoing anticoagulant therapy
Infection at the injection site
Severe obesity or anatomical difficulty precluding block performance
Cognitive impairment interfering with pain assessment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | YUKIKO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama 700-8505, Japan
TEL
086-225-2111
funkii_tim@yahoo.co.jp
Public contact
Name of contact person
| 1st name | YUKIKO |
| Middle name | |
| Last name | YOSHIDA |
Organization
Kawasaki Medical School General Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama 700-8505, Japan
TEL
086-225-2111
Homepage URL
funkii_tim@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical School General Medical Center
Institute
Department
Personal name
yoshida yukiko
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
Tel
086-462-1111
kenkyu-soudan@med.kawasaki-m.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
| 2026 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070161
