UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051191 |
|---|---|
| Receipt number | R000058386 |
| Scientific Title | Hyaluronidase versus verapamil as an Adjuvant to Bupivacaine in the Ultrasound-guided Serratus Anterior Block in Postoperative Pain Control for Modified Radical Mastectomy Cases |
| Date of disclosure of the study information | 2024/05/29 |
| Last modified on | 2023/05/29 21:34:24 |
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Basic information
Public title
Hyaluronidase versus verapamil as an Adjuvant to Bupivacaine in the Ultrasound-guided Serratus Anterior Block in Postoperative Pain Control for Modified Radical Mastectomy Cases
Acronym
Hyaluronidase versus verapamil as an Adjuvant to Serratus Anterior Block in Postoperative Pain Control for Modified Radical Mastectomy Cases
Scientific Title
Hyaluronidase versus verapamil as an Adjuvant to Bupivacaine in the Ultrasound-guided Serratus Anterior Block in Postoperative Pain Control for Modified Radical Mastectomy Cases
Scientific Title:Acronym
Hyaluronidase versus verapamil as an Adjuvant to Serratus Anterior Block in Postoperative Pain Control for Modified Radical Mastectomy Cases
Region
| Africa |
Condition
Condition
Serratus anterior block for post-operative pain in modified radical mastectomy
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
this study is to compare the efficacy and latency of adding Hyaluronidase or verapamil to Bupivacaine 0.25% ultrasound guided serratus plane block
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
this study is to compare the efficacy and latency of adding Hyaluronidase or verapamil to Bupivacaine 0.25% ultrasound guided serratus plane block
Key secondary outcomes
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
the efficacy of adding verapamil 2.5 mg to Bupivacaine 0.25% ultrasound guided serratus plane block regarding primarily to time to peak analgesic effect together with duration of analgesia
Interventions/Control_2
Adding hyaluronidase 3000 IU to Bupivacaine 0.25% ultrasound guided serratus plane block regarding primarily to time to peak analgesic effect together with duration of analgesia
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients scheduled for modified radical mastectomy will be included in this study
Key exclusion criteria
Exclusion criteria will be any patients with allergy to any test drugs, coagulopathy, infection at the nerve block puncture site, patients on of any analgesic drug within 48 h before surgery, history of chronic pain medication use, direct chest wall trauma or history of thoracic spine surgery, sinus bradycardia, and atrioventricular block
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Wafiya |
| Middle name | R |
| Last name | Mahdy |
Organization
Faculty of medicine Menofia university
Division name
Anesthesia, Intinsve care and pain management department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201094245826
wafia.mahdi@med.menofia.edu.eg
Public contact
Name of contact person
| 1st name | Ghada |
| Middle name | |
| Last name | Hassan |
Organization
Menofia University
Division name
Anesthesia, Intinsve care and pain management department
Zip code
32511
Address
Faculty of medicine, Menofia University, Egypt
TEL
00201001592001
Homepage URL
ghada.ibrahim@med.menofia.edu.eg
Sponsor or person
Institute
Faculty of medicine Menofia university, Egypt
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine Menofia university, Egypt
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
Faculty of medicine, Menofia University, Egypt
Address
Egyopt, Shebin El-Kom, Yassin Abdel Ghaffar street
Tel
00201094245826
wafia.mahdi@med.menofia.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
| 2024 | Year | 05 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058386
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| Registered date | File name |
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