UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045245 |
|---|---|
| Receipt number | R000051560 |
| Scientific Title | Evaluation of anesthetized dermatomal range obtained by single-bolus-shot subcostal TAP block in the patients undergoing laparoscopic cholecystectomy: A pilot study |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2022/08/25 16:31:44 |
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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
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
yabuki-shi@hospital.city.sendai.jp
Sponsor or person
Institute
Sendai City Hospital, department of anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051560
