UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034322 |
|---|---|
| Receipt number | R000039132 |
| Scientific Title | Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy. A randomized controlled study. |
| Date of disclosure of the study information | 2019/03/17 |
| Last modified on | 2018/09/29 16:13:42 |
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Basic information
Public title
Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy. A randomized controlled study.
Acronym
Superficial cervical plexus block for Trans-oral endoscopic thyroidectomy.
Scientific Title
Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy. A randomized controlled study.
Scientific Title:Acronym
Superficial cervical plexus block for Trans-oral endoscopic thyroidectomy.
Region
| Africa |
Condition
Condition
recruiting cases
Classification by specialty
| Endocrinology and Metabolism | Endocrine surgery | Anesthesiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
assess analgesic efficacy of cervical plexus block after general anesthesia for transoral thyroidectomy.
Basic objectives2
Others
Basic objectives -Others
hospital stay, total analgesic consumption, and side effects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary concern of this study is pain score.
Key secondary outcomes
The secondary goals are hospital stay, total analgesic consumption, and side effects.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
First group will receive general anesthesia. (Group G)
Interventions/Control_2
second group receive bilateral cervical plexus block after induction of general anesthesia. (Group B).
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for thyroid surgeries with gland width on diagnostic imaging less than 10 cm.
Key exclusion criteria
Exclusion criteria:Patients unfit for general anesthesia, Previous neck surgery or recurrent goiter, A gland more than 45 mL or distant metastases, Tracheal/esophageal infiltration, hyperthyroidism, mediastinal goiter, poorly- or un-differentiated cancer.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | alaa eldeeb |
Organization
Mansoura university
Division name
Anesthesia
Zip code
Address
samia, 5
TEL
+201225303563
alaaeldeep@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Alaaeldin ELDEEB |
Organization
Mansoura university
Division name
Anesthesia
Zip code
Address
Egypt,Mansoura
TEL
0546357335
Homepage URL
alaaeldeep9@hotmail.com
Sponsor or person
Institute
Mansoura university,anesthesia department
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2019 | Year | 03 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039132
