UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052412 |
|---|---|
| Receipt number | R000059812 |
| Scientific Title | Rhomboid intercostal block with subserratus plane block versus thoracic paravertebral block in video assisted thoracoscopic surgery a prospective randomized comparative study |
| Date of disclosure of the study information | 2023/10/05 |
| Last modified on | 2023/10/04 19:23:35 |
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Basic information
Public title
Rhomboid intercostal block with subserratus plane block versus thoracic paravertebral block in video assisted thoracoscopic surgery a prospective randomized comparative study
Acronym
Rhomboid intercostal block with subserratus plane block versus thoracic paravertebral block in video assisted thoracoscopic surgery
Scientific Title
Rhomboid intercostal block with subserratus plane block versus thoracic paravertebral block in video assisted thoracoscopic surgery a prospective randomized comparative study
Scientific Title:Acronym
Rhomboid intercostal block with subserratus plane block versus thoracic paravertebral block in video assisted thoracoscopic surgery
Region
| Africa |
Condition
Condition
retroactive
Classification by specialty
| Medicine in general | Chest surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare between Rhomboid intercostal subserratus plane block to thoracic paravertebral block in VAT surgery as regard degree of pain and total opioid consumption
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS score at rest and coughing at two-hour intervals for the first six hours after the procedure, then at 12, 18, and 24 hours
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PVB group, the patient was placed in the lateral position, and the transducer was placed in the thoracic parasagittal plane. We identified the thoracic paravertebral space at T4 - T7 levels. Then, a sono visible needle was advanced under ultrasound guidance to the plane between the pleural line and the overlying superior costotransverse ligament. After a negative aspiration test, 25 ml of bupivacaine 0.25% was administered into that plane, and we noticed anterior pleural displacement during the injection, ensuring delivery of the injectate into the proper plane.
Interventions/Control_2
RISS group: 10 ml of bupivacaine 0.25% was injected between rhomboid muscle and underlying intercostal muscle and the other 10 ml of of bupivacaine 0.25% was injected in the plane between intercostal and serratus anterior muscles by the aid of ultrasonography.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
adult patients of both sexes age between 18 to 70 years old ASA I-III scheduled for unilateral elective VATS
Key exclusion criteria
Patients with class more than III or higher were excluded from our study. Also, we excluded patients with any of the following criteria: age < 18 years, bleeding disorders, previous thoracic surgery, conversion to the open approach, or history of allergy to local anesthetic agents.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | mohammed |
| Middle name | adel |
| Last name | hegazy |
Organization
Mansoura university hospital
Division name
anesthesia and surgical intensive care department
Zip code
35511
Address
elgomhoreya street, Mansoura, Egypt
TEL
0020502205178
dr_mhegazy7000@mans.edu.eg
Public contact
Name of contact person
| 1st name | mohammed |
| Middle name | adel |
| Last name | hegazy |
Organization
Mansoura university hospital
Division name
anesthesia and surgical intensive care department
Zip code
35511
Address
elgomhoreya street, Mansoura, Egypt
TEL
0020502205178
Homepage URL
dr_mhegazy7000@mans.edu.eg
Sponsor or person
Institute
Mansoura university hospitals
Institute
Department
Personal name
Funding Source
Organization
Mansoura university hospitals
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Research Board - IRB Faculty of Medicine - Mansoura University
Address
elgomhoreya street, Mansoura, Egypt
Tel
+20 50 2202772
irb@mans.edu.eg
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 | 10 | Month | 05 | 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
62
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
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059812
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