UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046644 |
|---|---|
| Receipt number | R000053131 |
| Scientific Title | Single-center, randomized, parallel-group comparative study on efficacy and safety of preoperative peripheral nerve block-administered group and control group for human breast cancer with postoperative acute pain and persistent postoperative pain |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/01/14 16:46:04 |
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Basic information
Public title
Single-center, randomized, parallel-group comparative study on efficacy and safety of preoperative peripheral nerve block-administered group and control group for human breast cancer with postoperative acute pain and persistent postoperative pain
Acronym
Preventive effect of peripheral nerve block on acute pain and chronic postsurgical pain after breast cancer surgery
Scientific Title
Single-center, randomized, parallel-group comparative study on efficacy and safety of preoperative peripheral nerve block-administered group and control group for human breast cancer with postoperative acute pain and persistent postoperative pain
Scientific Title:Acronym
Preventive effect of peripheral nerve block on acute pain and chronic postsurgical pain after breast cancer surgery
Region
| Japan |
Condition
Condition
Patients scheduled for breast cancer surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For breast cancer surgery, perform peripheral nerve block to verify the preventive effect of postoperative acute pain and chronic pain.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of recovery and wound pain on the first day after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Do not perform peripheral nerve block before surgery
Interventions/Control_2
Perform PECS block
Interventions/Control_3
Perform retrolaminar block or MTP block
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
| 85 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients scheduled for breast cancer surgery at our hospital
Key exclusion criteria
Underage, taking antipsychotics, psychiatric patients, severe obesity(>=BMI35), men, patients with chronic pain, patients taking opioids and analgesics
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Sawamizu |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
3598513
Address
3-2, Namiki, Tokorozawa, Saitama, Japan
TEL
0429951511
doc34027@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Sawamizu |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
3598513
Address
3-2, Namiki, Tokorozawa, Saitama, Japan
TEL
0429951511
Homepage URL
doc34027@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Course research expense
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
3-2, Namiki, Tokorozawa, Saitama, Japan
Tel
0429951511
doc34027@ndmc.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
| 2022 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053131
