UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery.
Acronym	Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery.
Scientific Title	Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery.
Scientific Title:Acronym	Effects of Paravertebral versus Thoracic Wall Block on the Quality of Recovery after Breast Cancer Surgery.
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.
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	36

Research contact person
Name of lead principal investigator	1st name Toshinori Middle name Last name Horiuchi
Organization	Bellland General Hospital
Division name	Department of Anesthesia
Zip code	599-8247
Address	500-3, Higashiyama, Naka-Ku, Sakai, Osaka
TEL	072-234-2001
Email	t_horiuchi@seichokai.or.jp

Public contact
Name of contact person	1st name Toshinori Middle name Last name Horiuchi
Organization	Bellland 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
Email	t_horiuchi@seichokai.or.jp

Sponsor
Institute	Department of Anesthesia, Bellland 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	Bellland General Hospital Institutional Review Board
Address	500-3, Higashiyama, Naka-Ku, Sakai, Osaka
Tel	072-234-2001
Email	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	2016 Year 07 Month 28 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	Completed
Date of protocol fixation	2016 Year 06 Month 29 Day
Date of IRB	2016 Year 06 Month 29 Day
Anticipated trial start date	2016 Year 07 Month 28 Day
Last follow-up date	2018 Year 07 Month 28 Day
Date of closure to data entry	2018 Year 08 Month 28 Day
Date trial data considered complete	2018 Year 08 Month 28 Day
Date analysis concluded	2018 Year 09 Month 28 Day

Other
Other related information

Management information
Registered date	2016 Year 07 Month 26 Day
Last modified on	2019 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026399