UMIN-CTR Clinical Trial

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
Email	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
Email	s-yonemoto@juntendo.ac.jp

Sponsor
Institute	Juntendo University Shizuoka hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046182