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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2023/03/10 [生021-0021]研究計画書 ver.1.4【210906承認】.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name