UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045406 |
|---|---|
| Receipt number | R000051809 |
| Scientific Title | Evaluation of the chronological changes of plasma levobupivacaine concentration after performing M-TAPA. |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2023/05/28 16:14:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the chronological changes of plasma levobupivacaine concentration after performing M-TAPA.
Acronym
Evaluation of the chronological changes of plasma levobupivacaine concentration after performing M-TAPA.
Scientific Title
Evaluation of the chronological changes of plasma levobupivacaine concentration after performing M-TAPA.
Scientific Title:Acronym
Evaluation of the chronological changes of plasma levobupivacaine concentration after performing M-TAPA.
Region
| Japan |
Condition
Condition
The patients undergoing abdominal surgery longer than 2 hours under general anesthesia in conjunction with M-TAPA.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
M-TAPA is a novel truncus peripheral nerve block technique reported in 2019. As this technique require relatively large volume of local anesthetics, there are potential risk of local anesthetic toxicity. However, peak and chronological plasma concentration of local anesthetic after performing M-TAPA remains to be elucidated.
The purpose of this prospective observational study is to investigate plasma lovobupivacaine concentration by 2 hours after performing M-TAPA/
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The plasma levobupivacaine concentration at 10, 20, 30, 45, 60, 120 minutes after performing M-TAPA.
Key secondary outcomes
1. Correlation with plasma local anesthetic concentration and patient's characteristics.
2. Adverse events occurring within 12 hours after M-TAPA performance.
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
The patients undergoing abdominal surgery under generalanesthesia in conjunction with bilateral M-TAPA using 25ml 0.25% levobupivacaine mixed with 5ug/ml epinephrine.
Key exclusion criteria
1. ASA-PS >=3
2. Allergy to local anesthetics or epinephrine
3. Body weight <=50 kg
4. Existing hepatopathy or neuropathy
5. Pregnancy
6. Albumine <=3 g/dL
7. Other patients who are judged inappropriate by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Aikawa |
Organization
Hokkaido university hospital
Division name
Anesthesiology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
+81-11-706-7861
katsuhiro.aikawa@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Aikawa |
Organization
Hokkaido university hospital
Division name
Anesthesiology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
+81-11-706-7861
Homepage URL
katsuhiro.aikawa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital, department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university 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
Hokkaido university hospital clinical research and medical innovation center
Address
North 14, West 5, Kita-ku, Sapporo
Tel
+81-11-706-7061
crjimu@huhp.hokuda.ac.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
| 2021 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
25 mL of 0.25% levobupivacaine mixed with epinephrine was administered on each side. The highest individual peak and mean peak plasma concentration was 1.03 and 073, respectively.
Results date posted
| 2023 | Year | 05 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-arm prospective observational study.
Maruishi Pharmaceutical Cooperation (Osaka, Japan), which produces and distributes levobupivacaine in Japan, will provide us with technical support of levobupivacaine concentration measurement.
They will be involved in only measurement, and will not participate in data analysis.
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051809
