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UMIN-CTR Clinical Trial |
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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 | 2020/07/27 |
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 |
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Condition | |||
Condition | breast cancer | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 44 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Teine Keijinkai Hospital | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 0060811 | ||||||
Address | 1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan. | ||||||
TEL | 011-681-8111 | ||||||
kunio555@gmail.com |
Public contact | |||||||
Name of contact person |
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Organization | Teine Keijinkai Hospital | ||||||
Division name | Department of Anesthesiology | ||||||
Zip code | 0060811 | ||||||
Address | 1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan. | ||||||
TEL | 011-681-8111 | ||||||
Homepage URL | |||||||
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 | none |
Name of secondary funder(s) | none |
IRB Contact (For public release) | |
Organization | Teine Keijinkai Hospital |
Address | 1-40, 1-jo 12-chome, Maeda, Teine-ku, Sapporo, Hokkaido, Japan. |
Tel | 011-681-8111 |
nakahama@keijinkai.or.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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |