UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039651 |
|---|---|
| Receipt number | R000045226 |
| Scientific Title | A Combined Thoracic Interfascial Plane Block for Postoperative Pain Relief and Quality of Recovery after Breast Cancer Surgery: A Prospective, Observational Cohort Study |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/02/29 22:50:55 |
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Basic information
Public title
A Combined Thoracic Interfascial Plane Block for Postoperative Pain Relief and Quality of Recovery after Breast Cancer Surgery: A Prospective, Observational Cohort Study
Acronym
A Combined Thoracic Interfascial Plane Block for Postoperative Pain Relief and Quality of Recovery after Breast Cancer Surgery: A Prospective, Observational Cohort Study
Scientific Title
A Combined Thoracic Interfascial Plane Block for Postoperative Pain Relief and Quality of Recovery after Breast Cancer Surgery: A Prospective, Observational Cohort Study
Scientific Title:Acronym
A Combined Thoracic Interfascial Plane Block for Postoperative Pain Relief and Quality of Recovery after Breast Cancer Surgery: A Prospective, Observational Cohort Study
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 adversely affects the patient's daily life and reduces the quality of life. As a method of preventing chronic pain after breast cancer surgery, it is adequate to relieve acute pain immediately after surgery. As a method, peripheral nerve block performed on the chest wall was reported by Blanco et al., attracting attention as a low-risk analgesic method after breast surgery. Recently, many variants of this block have been reported, and some of them have been combined to provide a broader range of analgesia.
As an evaluation of postoperative analgesia, a VAS scale or NRS scale of pain is generally used, but in recent years, an analgesic method has been evaluated from the viewpoint of the quality of recovery after the operation (Quality of Recovery). However, no effect of the combination of peripheral nerve block of the chest wall as described above on the quality of postoperative recovery, has been reported.
The primary purpose of this study is to examine the effects of a combination of chest wall peripheral nerve blocks on pain and quality of recovery after breast surgery as a prospective observational study in the acute and chronic phases (up to one year after surgery).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual Analog Scale (VAS) pain score 3 hours after surgery
Key secondary outcomes
Visual Analog Scale (VAS) pain score for "morning following surgery" and "maximum until the morning after surgery."
Quality of Recovery (QoR-40; questionnaire consisting of 40 items) before and three days after surgery, 1, 3, 6, and 12 months after surgery.
Patient age, height, weight, gender
Surgery time
Total fentanyl usage, total remifentanil usage
Postoperative nausea and vomiting
Frequent use of postoperative analgesics
Time to need the first rescue analgesia
Whether there are complications associated with the block (vascular puncture, pneumothorax, hematoma, nerve damage, etc.)
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients undergoing breast cancer surgery at Bell Land General Hospital.
Key exclusion criteria
Patients who do not agree with this study, pregnant and parturient women, allergy to local anesthetics, significant psychiatric or mental disorders, patients with chronic pain.
Target sample size
30
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
0745381023
thoriuch@kcn.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
0722342001
Homepage URL
t_horiuchi@seichokai.or.jp
Sponsor or person
Institute
Department of Anesthesia, Bell Land 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
0722342001
rib@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
| 2020 | Year | 03 | 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
30
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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the primary outcome, the Visual Analog Scale (VAS) pain score 3 hours after surgery, and the secondary outcomes, which are:
Quality of Recovery (QoR-40; questionnaire consisting of 40 items) before and three days after surgery, 1, 3, 6, and 12 months after surgery.
Visual Analog Scale (VAS) pain score for "morning following surgery" and "maximum until the morning after surgery."
Patient age, height, weight, gender
Surgery time
Total fentanyl usage, overall remifentanil usage
Postoperative nausea and vomiting
Frequent use of postoperative analgesics
Time to need the first rescue analgetic
Whether there are complications associated with the block (vascular puncture, pneumothorax, hematoma, nerve damage, etc.)
Management information
Registered date
| 2020 | Year | 02 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045226
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