UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of anesthetized dermatomal range obtained by single-bolus-shot subcostal TAP block in the patients undergoing laparoscopic cholecystectomy: A pilot study
Acronym	Evaluation of anesthetized dermatomal range obtained by single-bolus-shot subcostal TAP block in the patients undergoing laparoscopic cholecystectomy: A pilot study
Scientific Title	Evaluation of anesthetized dermatomal range obtained by single-bolus-shot subcostal TAP block in the patients undergoing laparoscopic cholecystectomy: A pilot study
Scientific Title:Acronym	Evaluation of anesthetized dermatomal range obtained by single-bolus-shot subcostal TAP block in the patients undergoing laparoscopic cholecystectomy: A pilot study
Region	Japan

Condition
Condition	Cholelithiasis Cholecystitis Gallbladder polyp Gallbladder adenomyosis
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The Modified thoracoabdominal nerves block perichondrial approach (M-TAPA) is a trunk block that can be expected to have a wide anesthetized area on the anterior surface of the abdomen. However, in this block, the angle formed by the ultrasonic beam and the block needle tends to be acute, and the visibility of the block needle on the ultrasonic screen tends to deteriorate. On the other hand, in subcostal transversus abdominis plane block (TAP) and oblique subcostal TAP block, the angle formed by the ultrasonic beam and the block needle tends to be obtuse, so the visibility of the block needle on the ultrasonic screen is better. However, these blocks require simultaneous movement of the transducer and block needle to administer local anesthesia for a wide anesthetized area. We propose a single-bolus-shot subcostal TAP block. In this block, the linear transducer is placed at the 9th-10th costal cartilage level along the costal arch, and local anesthesia is administered between the internal oblique muscle and transverse abdominis muscle near the costal cartilage as single dose. If single-bolus-shot subcostal TAP block achieves the same anesthetized area as M-TAPA, it can be an alternative block to M-TAPA or oblique subcostal TAP block. This is the pilot study to evaluate the anesthetized area of single-bolus-shot subcostal TAP block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anesthetized areas at 2 hours after surgery (The area innervated by anterior branch and lateral cutaneous branch are evaluated separately)
Key secondary outcomes	Pain score (NRS) induced by coughing at 2 hours after surgery Additional analgesic requirements within 24 hours after surgery Adverse events associated with single-bolus-shot subcostal TAP block

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Laparoscopic cholecystectomy cases undergoing single-bolus-shot subcostal TAP block in addition to general anesthesia
Key exclusion criteria	1.Body weight < 45 kg 2. BMI >= 35 3. Past history of thoracotomy or laparotomy 4. Communication difficulty 5. Existing neuropathy 6. Prolongation of surgical time ( > 6 hours) 7. Insufficient recovery of consciousness at 2 hours after surgery 8. Pregnancy 9. Allergy to local anesthetics 10. Other patients who are judged inappropriate by the investigators
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Shizuha Middle name Last name Yabuki
Organization	Sendai City Hospital
Division name	Anesthesiology
Zip code	982-8502
Address	1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi
TEL	+81223087111
Email	yabuki-shi@hospital.city.sendai.jp

Public contact
Name of contact person	1st name Shizuha Middle name Last name Yabuki
Organization	Sendai City Hospital
Division name	Anesthesiology
Zip code	982-8502
Address	1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi
TEL	+81223087111
Homepage URL
Email	yabuki-shi@hospital.city.sendai.jp

Sponsor
Institute	Sendai City Hospital, department of anesthesiology
Institute
Department

Funding Source
Organization	Sendai City Hospital, department of anesthesiology
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	Sendai City Hospital
Address	1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi
Tel	+81223087111
Email	yabuki-shi@hospital.city.sendai.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	仙台市立病院（宮城県）/Sendai City Hospital (Miyagi)

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 24 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	2021 Year 08 Month 10 Day
Date of IRB	2021 Year 08 Month 10 Day
Anticipated trial start date	2021 Year 08 Month 24 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To evaluate the efficacy of single-bolus-shot subcostal TAP block in the anterior branch and lateral cutaneous branch separately, pinprick tests are performed at the points below; Anterior branch: within 5 cm from the vertical line through umbilicus. Lateral cutaneous branch: mid-axillary line.

Management information
Registered date	2021 Year 08 Month 24 Day
Last modified on	2022 Year 08 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051560