UMIN-CTR Clinical Trial

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
Email	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
Email	t_horiuchi@seichokai.or.jp

Sponsor
Institute	Department of Anesthesia, Bell Land General Hospital
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	Bell Land General Hospital Institutional Review Board
Address	500-3, Higashiyama, Naka-Ku, Sakai, Osaka
Tel	0722342001
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045226