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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032649
Receipt No. R000037228
Official scientific title of the study Ultrasound guided-modified approach local/regional anesthesia for thyroidectomy. A randomized controlled study.
Date of disclosure of the study information 2018/07/01
Last modified on 2018/05/20

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Basic information
Official scientific title of the study Ultrasound guided-modified approach local/regional anesthesia for thyroidectomy. A randomized controlled study.
Title of the study (Brief title) Ultrasound guided-modified approach local/regional anesthesia for thyroidectomy.
Region
Africa

Condition
Condition started
Classification by specialty
Endocrine surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim is to assess efficacy and safety of single-site superficial cervical plexus block combined with capsule-sheath space block in thyroidectomy. The primary concern of this study is patient satisfaction.
Basic objectives2 Others
Basic objectives -Others The secondary goals are surgeon satisfaction, pain scores, and side effects.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The aim is to assess efficacy and safety of single-site superficial cervical plexus block combined with capsule-sheath space block in thyroidectomy. The primary concern of this study is patient satisfaction.
Key secondary outcomes The secondary goals are surgeon satisfaction, pain scores, and side effects.

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 Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 First group, receive general anesthesia (Group G)
Interventions/Control_2 bilateral superficial cervical plexus block with marcaine 0.5 % combined with capsule-sheath space block
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients scheduled for thyroid surgeries who are ASA (physical status) I or II.
Key exclusion criteria Obstructive pulmonary disease, Diabetes
Neuropathy,Contralateral diaphragmatic paralysis, A history of allergic reaction to any of the study drugs ,Epilepsy,Neuromuscular disease, Hematological disorders,Thyroid malignancy,Recurrent thyroidectomy.
Target sample size 70

Research contact person
Name of lead principal investigator alaa eldeeb
Organization Mansoura university
Division name Anesthesia department
Address Egypt, mansoura university, mansoura university hospitals
TEL 0020502226261
Email alaaeldeep@gmail.com

Public contact
Name of contact person Alaa Eldeeb
Organization Mansoura university
Division name anesthesia department
Address Egypt, mansoura university, mansoura university hospitals
TEL 0020502226261
Homepage URL
Email alaaeldeep@gmail.com

Sponsor
Institute Egypt, mansoura university, mansoura university hospitals
Institute
Department

Funding Source
Organization self funding
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
2018 Year 07 Month 01 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 01 Day
Anticipated trial start date
2018 Year 03 Month 08 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 05 Month 20 Day
Last modified on
2018 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037228

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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