UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024253
Receipt No. R000027925
Scientific Title The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Date of disclosure of the study information 2016/10/03
Last modified on 2019/03/03

* 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 The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Acronym The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Scientific Title The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Scientific Title:Acronym The effect of Pectoral nerves block in breast cancer surgery; Randomized Controlled Trial
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare prospectively the quality of analgesia after mastectomy using general anesthesia and Pecs blocks versus general anesthesia alone.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Visual analog scale
Key secondary outcomes Verbal Rating Scales
The short-form McGill Pain Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 US guided pectoral nerves block (pecs 1 block and pecs 2 block) preoperatively under general anesthesia
Interventions/Control_2 general anesthesia alone
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
18 years-old <=
Age-upper limit
99 years-old >=
Gender Female
Key inclusion criteria patients who undergo partial or radical mastectomy
Key exclusion criteria patients who
#decline to give written informed consent,
#bilateral mastectomy,
#emergency or urgent case,
#history of allergy to the medications used in the study,
#contraindications to regional anesthesia (including coagulopathy and local infection),
#undergo concomitant breast reconstruction,
#dementia and psychiatric disorder
#Inhalation anesthesia
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunio Kusajima
Organization Teine Keijinkai Hospital
Division name Department of Anesthesiology
Zip code
Address 1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.
TEL 011-681-8111
Email kunio555@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Kunio Kusajima
Organization Teine Keijinkai Hospital
Division name Department of Anesthesiology
Zip code
Address 1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan.
TEL 011-681-8111
Homepage URL
Email kunio555@gmail.com

Sponsor
Institute Teine Keijinkai Hospital, Department of Anesthesiology
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2016 Year 10 Month 03 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 06 Day
Last follow-up date
2019 Year 05 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
2016 Year 10 Month 02 Day
Last modified on
2019 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.