UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055796 |
|---|---|
| Receipt number | R000063534 |
| Scientific Title | The efficacy of Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and External Oblipue Intercostal Block (EOIB) for laparoscopic cholecystectomy: a single-blinded randomised controlled trial |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2024/10/09 16:35:15 |
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Basic information
Public title
The efficacy of Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and External Oblipue Intercostal Block (EOIB) for laparoscopic cholecystectomy: a single-blinded randomised controlled trial
Acronym
The efficacy of Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and External Oblipue Intercostal Block (EOIB) for laparoscopic cholecystectomy: a single-blinded randomised controlled trial
Scientific Title
The efficacy of Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and External Oblipue Intercostal Block (EOIB) for laparoscopic cholecystectomy: a single-blinded randomised controlled trial
Scientific Title:Acronym
The efficacy of Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and External Oblipue Intercostal Block (EOIB) for laparoscopic cholecystectomy: a single-blinded randomised controlled trial
Region
| Japan |
Condition
Condition
laparoscopic cholecystectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and External Oblique Intercostal Block (EOIB) are new peripheral abdominal nerve block techniques that were reported in 2019 and 2021, respectively. The most recommended regional anaesthetic technique for laparoscopic cholecystectomy at present is wound infiltration (WI).
M-TAPA has been suggested to be superior to WI, but it is highly novel and there are also indications that it is technically difficult to perform.
EOIB is also thought to be effective for upper abdominal surgery, and it is attracting attention as a simpler technique because it targets the superficial fascia surface rather than the deeper surface under the external oblique muscle, making it easier to see.
However, while there are opinions that the fascia surface targeted by EOIB is not effective, there are also clinical reports that show it can produce a pain-free area, so its evaluation is still undecided.
If it is clinically useful, it has the potential to be easily performed because the technique is simple.
There have been no studies comparing the new techniques of M-TAPA and EOIB, so we decided to plan a non-inferiority study using M-TAPA as a control, taking into account the concerns about EOIB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Values and changes 1 and 2 days after surgery compared to pre-surgery values for QOR-15
Key secondary outcomes
NRS at 2, 12, 24 and 48 hours after surgery
skin sensitivity evaluation using the pinprick test at 2 hours
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)
Interventions/Control_2
External Oblique Intercostal Block(EOIB)
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing laparoscopic cholecystectomy
Patients classified as American Society of Anesthesiologists 1~2
Patients aged 20~85 years
Patients who have given written consent to participate in the study
Key exclusion criteria
Patients undergoing emergency surgery on the day of the procedure
Patients who are chronically using opioids
Patients who are allergic to local anaesthetics
Patients who are unable to give consent
Patients with abnormal coagulation function
Patients receiving antithrombotic therapy and who do not meet the criteria for a sufficient drug withdrawal period in accordance with the Guidelines for Regional Anesthesia and Nerve Block during Antithrombotic Therapy
Patients judged by the principal investigator or sub-investigator to be unsuitable for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamanaka |
Organization
Nara Prefecture General Medical Center
Division name
Anaesthesiology
Zip code
630-8581
Address
2-897-5, Shichijo-nishi, Nara city, Nara
TEL
0742-46-6001
yamachan_19881120@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Yamanaka |
Organization
Nara Prefecture General Medical Center
Division name
Anaesthesiology
Zip code
630-8581
Address
2-897-5, Shichijo-nishi, Nara city, Nara
TEL
0742-46-6001
Homepage URL
yamachan_19881120@yahoo.co.jp
Sponsor or person
Institute
Nara Prefecture General Medical Center
Institute
Department
Personal name
Takayuki Yamanaka
Funding Source
Organization
Nara Prefecture General Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Prefecture General Medical Center
Address
2-897-5, Shichijo-nishi, Nara city, Nara
Tel
0742-46-6001
yamachan_19881120@yahoo.co.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
奈良県総合医療センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | 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
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063534
