UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062393 |
|---|---|
| Receipt number | R000071407 |
| Scientific Title | Comparative Evaluation between Ultrasound Guided Rhomboid Intercostal Block, Pectoral Nerve block and Erector Spinae Plane Block for Pain Control In Breast Surgeries: A Prospective Randomized Study |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/29 20:44:07 |
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Basic information
Public title
Comparative Evaluation between Ultrasound Guided Rhomboid
Intercostal Block, Pectoral Nerve block and Erector Spinae Plane Block
for Pain Control In Breast Surgeries: A Prospective Randomized Study
Acronym
Comparative Evaluation between Ultrasound Guided Rhomboid
Intercostal Block, Pectoral Nerve block and Erector Spinae Plane Block
for Pain Control In Breast Surgeries: A Prospective Randomized Study
Scientific Title
Comparative Evaluation between Ultrasound Guided Rhomboid
Intercostal Block, Pectoral Nerve block and Erector Spinae Plane Block
for Pain Control In Breast Surgeries: A Prospective Randomized Study
Scientific Title:Acronym
Comparative Evaluation between Ultrasound Guided Rhomboid
Intercostal Block, Pectoral Nerve block and Erector Spinae Plane Block
for Pain Control In Breast Surgeries: A Prospective Randomized Study
Region
| Africa |
Condition
Condition
prospective randomized study
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare the analgesic effect of Rhomboid Intercostal Block (RIB), Pectoral Nerve Block (PECS II), and Erector Spinae Plane Block (ESP) for pain management in patients undergoing breast surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase III
Assessment
Primary outcomes
determine 24 hours opioid consumption
Key secondary outcomes
intraoperative hemodynamics
intraoperative fentanyl consumption
visual analogue scale(VAS)
patient satisfaction
time for first call analgesia
block performance
time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A (15 patients); Rhomboid Intercostal Block Group; patients
will receive general anesthesia initially then RIB
Interventions/Control_2
Group B (15 patients); Pectoral Nerve Block Group; patients will
receive general anesthesia initially then PECs.
Interventions/Control_3
Group C (15 patients); Erector Spinae Block Group; patients will
receive general anesthesia initially then ESP.
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
| 21 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Female patients aged 21 to 60 years old.
ASA I-II physical status.
BMI 30 kg/m2.
Key exclusion criteria
Patient refusal
History of allergy to local anesthetics.
Local sepsis at needle insertion site.
Coagulopathy.
Neuropathic and psychological disorders (unable to cooperate).
ASA classification 3.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | noha |
| Middle name | |
| Last name | afify |
Organization
faculty of medicine menoufia university
Division name
department of anesthesia
Zip code
32511
Address
25- yassen abdel ghaffar - shebin elkom
TEL
01069113014
nohaafify2014@gmail.com
Public contact
Name of contact person
| 1st name | noha |
| Middle name | |
| Last name | afify |
Organization
faculty of medicine menoufia university
Division name
department of anesthesia
Zip code
32511
Address
25- yassen abdel ghaffar - shebin elkom
TEL
01069113014
Homepage URL
nohaafify2014@gmail.com
Sponsor or person
Institute
faculty of medicine - menoufia university
Institute
Department
Personal name
noha afify
Funding Source
Organization
faculty of medicine menoufia 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
faculty of medicine menoufia university
Address
Egypt - Menoufia - Shebin el-kom - Yassin Abdel Ghaffar St
Tel
0482330325
medcine@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
| 2026 | Year | 07 | Month | 30 | 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
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 01 | 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
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071407
