UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055424 |
|---|---|
| Receipt number | R000063339 |
| Scientific Title | Fluoroscopic Guided Thoracic Continuous Erector Spinae Plane Block versus Lumbar Continuous Epidural Anesthesia for Patients Undergoing Open Nephrectomy: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2024/09/25 18:20:22 |
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Basic information
Public title
Fluoroscopic Guided Thoracic Continuous Erector Spinae Plane Block versus Lumbar Continuous Epidural Anesthesia for Patients Undergoing Open Nephrectomy:
A Randomized Controlled Trial
Acronym
Fluoroscopic Guided Thoracic Continuous Erector Spinae Plane Block versus Lumbar Continuous Epidural Anesthesia for Patients Undergoing Open Nephrectomy:
A Randomized Controlled Trial
Scientific Title
Fluoroscopic Guided Thoracic Continuous Erector Spinae Plane Block versus Lumbar Continuous Epidural Anesthesia for Patients Undergoing Open Nephrectomy:
A Randomized Controlled Trial
Scientific Title:Acronym
Fluoroscopic Guided Thoracic Continuous Erector Spinae Plane Block versus Lumbar Continuous Epidural Anesthesia for Patients Undergoing Open Nephrectomy:
A Randomized Controlled Trial
Region
| Africa |
Condition
Condition
randomized control trial
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare the efficacy of fluoroscopic guided thoracic continuous erector spinae block and lumbar continuous epidural anesthesia for pain management after open nephrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients requiring opioid consumption in the first day after surgery.
Key secondary outcomes
first call for analgesia
Total opioid consumption in the first day after surgery.
Visual Analogue score
Complications occurrence.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group I: Thoracic Erector Spinae Block (ESB)
Interventions/Control_2
Group II: Lumbar Epidural Block (LEB)
Interventions/Control_3
Group III: Control (C)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Both sex
physical status ASA I and II
Age 20-65 years
Elective open nephrectomy.
Key exclusion criteria
Patient refusal.
Patient with neurological deficit.
Patient with bleeding disorders.
Uncooperative patient.
Infection at the block injection site.
Patients with history of allergy to local anesthetics.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | noha |
| Middle name | abd allah |
| 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 | abd allah |
| 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
| 2024 | Year | 10 | Month | 15 | 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
| 2021 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063339
