UMIN-CTR Clinical Trial

Basic information
Public title	Consideration of the validity of Thoracoabdominal nerves through perichondral approach Block to laparoscopic cholecystectomy and laparoscopic colectomy
Acronym	Consideration of the validity of Thoracoabdominal nerves through perichondral approach Block to laparoscopic cholecystectomy and laparoscopic colectomy
Scientific Title	Consideration of the validity of Thoracoabdominal nerves through perichondral approach Block to laparoscopic cholecystectomy and laparoscopic colectomy
Scientific Title:Acronym	Consideration of the validity of Thoracoabdominal nerves through perichondral approach Block to laparoscopic cholecystectomy and laparoscopic colectomy
Region	Japan

Condition
Condition	laparoscopic cholecystectomy laparoscopic colectomy
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Up to now, epidural anesthesia has been performed as perioperative analgesia for trunk surgery, but peripheral nerve blocks have been increasing in recent years. This is due to an increase in contraindications for epidural anesthesia due to anticoagulant therapy and advances in ultrasound diagnostic equipment. TAP blocks have been used for abdominal analgesia, but TAP blocks required two punctures for upper or lower abdominal surgery. The TAPA block reported in 2019 is said to be possible with two punctures for cases requiring upper and lower abdominal pain during trunk surgery. Reducing the number of punctures would avoid complications and would be very useful if analgesia of the entire abdominal wall could be achieved with two punctures. However, prospective studies on the analgesic effects of TAPA block have not been conducted yet. In this study, we examine the effectiveness of TAPA block in trunk surgery by conducting a randomized controlled trial.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	opioid consumption within 48 hours after surgery
Key secondary outcomes	NRS side effects

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	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	TAPA block
Interventions/Control_2	IVPCA
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 undergoing laparoscopic colorectomy and laparoscopic cholecystectomy in the operating room of Juntendo University School of Medicine Shizuoka Hospital
Key exclusion criteria	Patients with bronchial asthma Patients with reduced renal function (eGFR <30) Patients who moved to open surgery Patients with lesions that are not suitable for puncturing the skin at the puncture site Patients with a history of allergy to local anesthetics Patients who are considered to be at risk of performing the procedure Other patients who are judged inappropriate by the investigator
Target sample size	28

Research contact person
Name of lead principal investigator	1st name masateru Middle name Last name kumemura
Organization	Juntendo university Shizuoka hospital
Division name	anesthesiology
Zip code	410-2295
Address	1129 Nagaoka, Izunokuni, Shizuoka Prefecture
TEL	055-948-3111
Email	m-kumemura@juntendo.ac.jp

Public contact
Name of contact person	1st name masateru Middle name Last name kumemura
Organization	juntendo university shizuoka hospital
Division name	anesthesiology
Zip code	410-2295
Address	1129 Nagaoka, Izunokuni, Shizuoka Prefecture
TEL	055-948-3111
Homepage URL
Email	m-kumemura@juntendo.ac.jp

Sponsor
Institute	Nintendo university shizuoka hospital
Institute
Department

Funding Source
Organization	Nintendo university shizuoka hospital
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, Shizuoka Prefecture
Tel	055-948-3111
Email	m-kumemura@juntendoaac.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 02 Month 04 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	Completed
Date of protocol fixation	2020 Year 01 Month 21 Day
Date of IRB	2020 Year 02 Month 10 Day
Anticipated trial start date	2020 Year 02 Month 11 Day
Last follow-up date	2020 Year 05 Month 30 Day
Date of closure to data entry	2020 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044855