UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040463 |
|---|---|
| Receipt number | R000046182 |
| Scientific Title | Comparison of the efficacy of TAPA block and TAP block for laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2021/06/22 06:23:47 |
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Basic information
Public title
Comparison of the efficacy of TAPA block and TAP block for laparoscopic cholecystectomy
Acronym
Comparison of the efficacy of TAPA block and TAP block for laparoscopic cholecystectomy
Scientific Title
Comparison of the efficacy of TAPA block and TAP block for laparoscopic cholecystectomy
Scientific Title:Acronym
Comparison of the efficacy of TAPA block and TAP block for laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
gallstone disease
Acute cholestasis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although TAP block has been widely used in laparoscopic cholecystectomy, comprehensive analgesia of the wound is difficult to achieve with TAP block alone. For this reason, postoperative analgesia is provided with narcotics and NSAIDs. However, although the TAPA block reported in 2019 has only been reported in case reports, it is said to be capable of providing total abdominal analgesia. In addition, the TAPA block requires fewer punctures and reduces the number of puncture-related complications. To date, there have been no prospective studies on the analgesic effect of TAPA block, and in this study, we will compare the efficacy of TAPA block and TAP block for laparoscopic cholecystectomy by conducting a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of opioids administered for analgesic purposes within 24 hours postoperatively
Key secondary outcomes
NRS up to 24 hours postoperatively
Presence of side effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
TAPA block
Interventions/Control_2
TAP 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 20 years of age undergoing laparoscopic cholecystectomy at the operating room of Juntendo University Shizuoka Hospital
Key exclusion criteria
(1) Patients with bronchial asthma
(2) Patients with impaired renal function (eGFR<30)
(3) Patients who have been converted to open abdominal surgery
(4) Patients with unsuitable skin lesions at the puncture site
(5) Patients who have a history of allergy to local anesthetics
(6) Patients for whom the procedure is considered dangerous
(7) Other patients deemed unsuitable as subjects by the investigators.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | shuhei |
| Middle name | |
| Last name | yonemoto |
Organization
Juntendo University Shizuoka hospital
Division name
anesthesiology
Zip code
410-2295
Address
1129 Nagaoka Izunokuni-city Shizuoka, Japan
TEL
055-948-3111
s-yonemoto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | shuhei |
| Middle name | |
| Last name | yonemoto |
Organization
Juntendo University Shizuoka hospital
Division name
anesthesiology
Zip code
410-2295
Address
1129 Nagaoka Izunokuni-city Shizuoka, Japan
TEL
055-948-3111
Homepage URL
s-yonemoto@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Shizuoka hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Juntendo University Shizuoka hospital
Address
1129 Nagaoka Izunokuni-city Shizuoka, Japan
Tel
055-948-3111
s-yonemoto@juntendo.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
| 2020 | Year | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 06 | 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
| 2020 | Year | 05 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046182
