UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037262 |
|---|---|
| Receipt number | R000042484 |
| Scientific Title | Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery (Re-evaluation). |
| Date of disclosure of the study information | 2019/07/04 |
| Last modified on | 2022/07/06 20:22:04 |
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Basic information
Public title
Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery (Re-evaluation).
Acronym
Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery (Re-evaluation).
Scientific Title
Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery (Re-evaluation).
Scientific Title:Acronym
Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery (Re-evaluation).
Region
| Japan |
Condition
Condition
Patients undergoing breast cancer surgery
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Chronic pain after breast cancer surgery has harmful effects on patients' daily life. Paravertebral block can prevent not only acute but chronic pain after breast cancer surgery, although the block is not easily put into practice because of technical difficulty or necessity to change patients' position. Recently, thoracic wall blocks have been reported by Blanco and in hope that it gives similar analgesic efficacy as paravertebral block with less risks, however there are no reports comparing analgesic efficacy of paravertebral block with thoracic wall blocks. Although there are several scales evaluating postoperative pain including VAS or NRS, Quality of Recovery (QoR) have been set up to assess the impact of postoperative morbidity on patients' ability to return to normal function and quality of life. Among those assessment scales, QoR-40 has been mainly applied. It consists of 40 questions including five dimensions: psychologic support, physical comfort, emotional state, physical independence, and pain, and there is a report suggesting that paravertebral block improve QoR-40 after ambulatory breast tumor resection. In this randomized, noninferiority trial, we hypothesized that thoracic wall blocks provides preserving effect of QoR-40 at least as good as paravertebral block after breast cancer surgery.
This study re-evaluates a previous study (UMIN000023340) with calculating the sample size achieved from the previous study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
QoR(Quality of Recovery)-40 on the day after surgery
Key secondary outcomes
QoR-40 on the day before surgery
QoR-40 three days, 1, 3, 6, 12 months after surgery
Visual Analog Scale (VAS) for pain one hour after surgery, on the day after surgery
VAS for pain three days, 1, 3, 6, 12 months after surgery
Patients' age, height, body weight, sex
total dose of fentanyl and remifentanil
frequency of analgesics' usage
frequency of postoperative nausea and vomiting
time from applying blocks to first analgesics' usage
complications (e.g. vascular pancture, pneumothorax, hematoma, neuronal injury)
frequency of recurrence
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
paravertebral block before breast surgery using ropivacaine 150mg.
Interventions/Control_2
thoracic wall block before breast surgery using ropivacaine 150mg.
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
patients undergoing breast cancer surgery at Bellland General ospital.
Key exclusion criteria
Patients who do not agree with this study, pregnant and parturient women, allergy to rocal anesthetics, significant psychiatric or mental disorders, patients with chronic pain.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Horiuchi |
Organization
Bell Land General Hospital
Division name
Department of Anesthesia
Zip code
599-8247
Address
500-3, Higashiyama, Naka-Ku, Sakai, Osaka
TEL
072-234-2001
t_horiuchi@seichokai.or.jp
Public contact
Name of contact person
| 1st name | Toshinori |
| Middle name | |
| Last name | Horiuchi |
Organization
Bell Land General Hospital
Division name
Department of Anesthesia
Zip code
599-8247
Address
500-3, Higashiyama, Naka-Ku, Sakai, Osaka
TEL
072-234-2001
Homepage URL
t_horiuchi@seichokai.or.jp
Sponsor or person
Institute
Department of Anesthesia, Bellland General Hospital
Institute
Department
Personal name
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
Bell Land General Hospital Institutional Review Board
Address
500-3, Higashiyama, Naka-Ku, Sakai, Osaka
Tel
072-234-2001
irb@bh.seichokai.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
ベルランド総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 04 | 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
73
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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
| 2029 | Year | 07 | Month | 28 | Day |
Date trial data considered complete
| 2029 | Year | 07 | Month | 28 | Day |
Date analysis concluded
| 2029 | Year | 08 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042484
