UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy. A randomized controlled study.
Title of the study (Brief title)	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	alaa eldeeb
Organization	Mansoura university
Division name	Anesthesia
Address	samia, 5
TEL	+201225303563
Email	alaaeldeep@gmail.com

Public contact
Name of contact person	Alaaeldin ELDEEB
Organization	Mansoura university
Division name	Anesthesia
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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