UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039333 |
|---|---|
| Receipt number | R000044855 |
| Scientific Title | Consideration of the validity of Thoracoabdominal nerves through perichondral approach Block to laparoscopic cholecystectomy and laparoscopic colectomy |
| Date of disclosure of the study information | 2020/02/04 |
| Last modified on | 2020/12/17 12:43:15 |
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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
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
m-kumemura@juntendo.ac.jp
Sponsor or person
Institute
Nintendo university shizuoka hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044855
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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