UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035497
Receipt No. R000040446
Scientific Title Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy. A randomized controlled study.
Date of disclosure of the study information 2019/01/19
Last modified on 2019/01/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy. A randomized controlled study.
Acronym Bilateral 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 Bilateral superficial cervical plexus block for Trans-oral endoscopic thyroidectomy.
Region
Africa

Condition
Condition recuriting
Classification by specialty
Endocrine surgery Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 . The aim is to assess analgesic efficacy of cervical plexus block after general anesthesia for transoral thyroidectomy. The primary concern of this study is pain score. The secondary goals are hospital stay, total analgesic consumption, and side effects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes . The aim is to assess analgesic efficacy of cervical plexus block after general anesthesia for transoral thyroidectomy. 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 Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 First group will receive general anesthesia. (Group G)
Interventions/Control_2 second group will receive bilateral superficial cervical plexus block with ropivacaine 0.5 % after general anesthesia (Group GB).
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for thyroid surgeries who are ASA (physical status) I or II or III with Gland width on diagnostic imaging less than ten ml, Outline of more than forty five cm ,Papillary microcarcinoma without local or distant.
Key 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 Alaaeldin ELDEEB
Organization Mansoura university
Division name anesthesia department
Zip code
Address Egypt
TEL 01225303563
Email alaaeldeep9@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Alaaeldin ELDEEB
Organization Mansoura university
Division name anesthesia department
Zip code
Address Egypt
TEL +2050226261
Homepage URL
Email alaaeldeep9@hotmail.com

Sponsor
Institute Mansoura university
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Dr.

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 01 Month 19 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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 21 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
2019 Year 01 Month 09 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040446

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.