UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055422 |
|---|---|
| Receipt number | R000063338 |
| Scientific Title | dexmedetomidine in erector spinea plane block for postoperative analgesia after laparoscopic cholecystectomy : A randomized trial. |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2024/09/25 18:23:35 |
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Basic information
Public title
dexmedetomidine in erector spinea plane block for postoperative analgesia after laparoscopic cholecystectomy : A randomized trial.
Acronym
dexmedetomidine in erector spinea plane block for postoperative analgesia after laparoscopic cholecystectomy : A randomized trial.
Scientific Title
dexmedetomidine in erector spinea plane block for postoperative analgesia after laparoscopic cholecystectomy : A randomized trial.
Scientific Title:Acronym
dexmedetomidine in erector spinea plane block for postoperative analgesia after laparoscopic cholecystectomy : A randomized trial.
Region
| Africa |
Condition
Condition
prospective randomized study
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficacy of dexmedetomidine in ESPB for postoperative analgesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase III
Assessment
Primary outcomes
postoperative analgesic duration
Key secondary outcomes
Postoperative pain in the first 24 h post-operative
Total dose of intraoperative consumption of fentanyl
Total dose of rescue analgesia in the first 24hr postoperative.
sedation score at recovery
patient satisfaction
recovery quality
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group I: (Control group): 30 patients were undergoing bilateral Erector
Spinae Plane Block at T7 level with 20 ml 0.25% bupivacaine + 1ml normal
saline on each side.
Interventions/Control_2
Group II: (Dexmedetomidine group): 30 patients were undergoing
bilateral Erector Spinae Plane Block at T7 level with 20 ml 0.25% bupivacaine +
0.5 microgram/kg dexmedetomidine diluted in 1 ml normal saline on each side.
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gender: male and female.
Patients aged between 30 and 65 years.
Scheduled to undergo laparoscopic cholecystectomy.
American Society of Anesthesiology (ASA) physical status
classification score of I or II.
Key exclusion criteria
History of allergy to the study drugs.
Inability to communicate or any other psychological
problems.
Sinus bradycardia.
Atrioventricular (AV) block.
Any contraindications to regional block.
Target sample size
60
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
| 2022 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | 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=R000063338
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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