UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032571 |
|---|---|
| Receipt number | R000035044 |
| Scientific Title | Ropivacaine plasma levels following nerve block on thoracic plane. |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2023/01/08 18:56:16 |
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Basic information
Public title
Ropivacaine plasma levels following nerve block on thoracic plane.
Acronym
Plasma concentration of ropivacaine after nerve block on thoracic wall.
Scientific Title
Ropivacaine plasma levels following nerve block on thoracic plane.
Scientific Title:Acronym
Plasma concentration of ropivacaine after nerve block on thoracic wall.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There are some reports which showed the pharmacokinetics of local anesthetics after abdominal wall block, but no report following chest wall. The purpose of this study is to evaluate the maximum total and ropivacaine concentrations and corresponding maximum times of plasma ropivacaine concentration after nerve blocks for chest wall.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma ropivacaine concentration
The timings of sampling are 2.5,5,10,15,30,45,60,90,120min after peripheral nerve block.
Key secondary outcomes
Clinical symptom of local anesthetic toxicity
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
Female
Key inclusion criteria
elective surgery of breast cancer
Key exclusion criteria
1)under 20 years old
2)Hard to communication
3)Unable to establish the informed consent
4)Hepatic dysfunction
5)Renal dysfunction
6)serum albumin under 3.0g/dl
7)Allergy to amid type local anesthetic
8)Medication of antiarrysmitic drug
9)Medication of anticoagulants/anti-plateletdrug
10)Coagulopathy PT-INR >1.5
11)Any other confition whitch treated as contraindication of peripheral nerve blck
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | AKIHITO |
| Middle name | |
| Last name | KAKINUMA |
Organization
Teikyo university shcool of medicine hospital
Division name
Anesthesia
Zip code
1738606
Address
Kaga 2-11-1 Itabashi-ku Tokyo
TEL
0339641211
icg02177@nifty.com
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Kakinuma |
Organization
Teikyo university shcool of medicine hospital
Division name
Anesthesisa
Zip code
1738606
Address
Kaga 2-11-1 Itabashi-ku Tokyo
TEL
0339641211
Homepage URL
icg02177@nifty.com
Sponsor or person
Institute
Teikyo university school of medicine
Anesthetic department
Institute
Department
Personal name
Funding Source
Organization
Medeical office research expenses
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Teikyo univesity
Address
Kaga2-11-1 Itabashi-ku Tokyo Japan
Tel
0339647256
turb-office@teikyo-u.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
帝京大学医学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
https://jsa-shoroku.jp/search/detail_program/id:2017
Publication of results
Published
Result
URL related to results and publications
https://jsa-shoroku.jp/search/detail_program/id:2017
Number of participants that the trial has enrolled
16
Results
No side effects related to local anesthetics were observed; one patient was excluded due to protocol deviation. The maximum blood concentration in all groups was 946+/- 374 ng/ml, and the time to Cmax was 22.5+/-9.5 minutes. Both groups showed no difference in patient background. Tmax was not significantly different between the two groups. There was also a significant difference in blood concentration at 2 hours between the TTP group and the non-TTP group.
Results date posted
| 2023 | Year | 01 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who have elective breast surgery
Accept the informed consent of this study
Participant flow
Non randamized study.
This sutdy was undergone to the participant who accepted the informed consent and the case was done as scheduled.
Adverse events
none
Outcome measures
Primary outcome
1)Serum Ropivacaine concentration in each measuring points
2)Peak serum Ropivacaine concentration (C max)
3)Time to peak serum Ropivacaine concentration (T max)
Secondary outcome
1)Clinical symptom of local anesthetic toxicity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
#Observational study
#period March 2019 from 2018 Jun,
#Recruitment
1:Recruiting peoriod: From Febrary 2018 to March 2019
2:Breast cancer surgery planed in our facility
3:Matched our exlusion criteria
4:Obtained infrormed concent
5:16 cases
Management information
Registered date
| 2018 | Year | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035044
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| Registered date | File name |
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