UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053100 |
|---|---|
| Receipt number | R000060597 |
| Scientific Title | The effect of paravertebral block on the contralateral side: A prospective observational study in breast surgery |
| Date of disclosure of the study information | 2023/12/14 |
| Last modified on | 2024/04/30 16:34:44 |
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Basic information
Public title
The effect of paravertebral block on the contralateral side: A prospective observational study in breast surgery
Acronym
The effect of paravertebral block on the contralateral side: A prospective observational study in breast surgery
Scientific Title
The effect of paravertebral block on the contralateral side: A prospective observational study in breast surgery
Scientific Title:Acronym
The effect of paravertebral block on the contralateral side: A prospective observational study in breast surgery
Region
| Japan |
Condition
Condition
Patients undergoing breast surgery (unilateral total mastectomy) due to anticipated breast cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate (1) whether paravertebral block (PVB) acts bilaterally and (2) whether the effect on the contralateral side varies with the volume of local anesthetic used, by performing PVB with two different volumes (mL) of local anesthetic in breast surgery and investigating contralateral skin sensation immediately after the surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensory block area and sensory decline area of the skin of the chest wall on both sides
Key secondary outcomes
Sensory block area and decline area of bilateral chest wall skin between low and high volume groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ultrasound-guided PVB with 15 mL of 0.75% ropivacaine near the 4th-5th thoracic spine on the operative side (low volume group).
Interventions/Control_2
Ultrasound-guided PVB with 30 mL of 0.375% ropivacaine near the 4th-5th thoracic spine on the operative side (high volume group).
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing breast surgery (unilateral total mastectomy and/or axillary lymph node dissection) under general anesthesia at Aidu Chuo Hospital after December 2023 who meet all three of the following criteria.
1) 18 years of age or older
2) Scheduled to undergo general anesthesia, and an American Society of Anesthesiologists physical status classification of 1-3
3) Written consent for participation in the study has been obtained from the patient or the patient's family.
Key exclusion criteria
One of the following applies:
(1) Bilateral surgery is planned
(2) Weight less than 40 kg or BMI more than 30 kg/m2
(3) History of spontaneous pneumothorax
(4) General contraindications to PVB (e.g., continued use of anticoagulants or antiplatelet agents)
(5) Inability to report the extent of effect immediately after surgery due to delayed awakening, etc
(6) Cases in which PVB was attempted but the drug was administered in a shallow layer, resulting in MTPB or ESPB
(7) Patient has difficulty in communication due to cognitive decline, hearing loss, etc.
(8) Patients with decreased sensation (e.g., after cerebral infarction)
(9) Other patients who are judged to be incompatible by the anesthesiologist (e.g., patients with severe obstructive lung disease that could be fatal if pneumothorax occurs).
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1, Hikarigaoka, Fukushima, Fukushima
TEL
0245471342
kei-y7of@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1-Hikarigaoka, Fukushima, Fukushima
TEL
0245471342
Homepage URL
kei-y7of@fmu.ac.jp
Sponsor or person
Institute
Aidu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
IRB of Aidu Chuo Hospital
Address
1-1, Tsurugamachi, Aizuwakamatsu, Fukushima
Tel
0242251515
kanoh@onchikai.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
| 2023 | Year | 12 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The area of the decrease of skin sensation is examined and recorded by applying a piece of ice to the midaxillary line and midclavicular line (cold test) and touching with a 22G needle with a blunt tip (pinprick test).
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060597
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