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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034322
Receipt No. 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

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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
Email 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
Email alaaeldeep9@hotmail.com

Sponsor
Institute Mansoura university,anesthesia department
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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