UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025343
Receipt No. R000029162
Scientific Title Superficial cervical plexus block in thyroid surgery. The effect of adding dexamethasone. A randomized double-blinded study.
Date of disclosure of the study information 2016/12/31
Last modified on 2017/01/17

* 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 Superficial cervical plexus block in thyroid surgery. The effect of adding dexamethasone. A randomized double-blinded study.
Acronym The effect of dexamethasone in superficial cervical plexus block in thyroid surgery.
Scientific Title Superficial cervical plexus block in thyroid surgery. The effect of adding dexamethasone. A randomized double-blinded study.
Scientific Title:Acronym The effect of dexamethasone in superficial cervical plexus block in thyroid surgery.
Region
Africa

Condition
Condition Going
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 compare effect of dexamethasone in association with superficial cervical plexus block in patients undergoing thyroid surgery by two routes; intravenous and perineural.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the primary concern is to compare effect of dexamethasone in association with superficial cervical plexus block in patients undergoing thyroid surgery by two routes; intravenous and perineural.
Key secondary outcomes The secondary goals are effect upon pain scores, PONV, and hospital stay.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 First group received BSCPB with ropivacaine 0.2 %plus 1ml normal saline intravenously (Group C)
Interventions/Control_2 second group received BSCPB with ropivacaine 0.2%, 8mg dexamethazone in the block plus 1ml normal saline intravenously (Group DB)
Interventions/Control_3 third group received BSCPB with ropivacaine 0.2 % plus 1ml dexamethazone (8mg) intravenously (Group DI).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA (physical status) I or II. undergoing thyroid surgeries
Key exclusion criteria obstructive pulmonary disease, diabetes, neuropathy, history of allergy to any of the used drugs, epilepsy, neuromuscular disease, or hematological disorders
Target sample size 94

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Khaled Elbahrawy
Organization Mansoura university hospital
Division name Anesthesia
Zip code
Address Egypt,Mansoura
TEL 0020502202515
Email Elbahrawy_khaled@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Dr Khaled Elbahrawy
Organization Mansoura university hospital
Division name Anesthesia
Zip code
Address Egypt
TEL 0020502202515
Homepage URL
Email Elbahrawy_khaled@yahoo.com

Sponsor
Institute Anesthesia department Mansoura university
Institute
Department

Funding Source
Organization NO fund
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
2016 Year 12 Month 31 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 Terminated
Date of protocol fixation
2016 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
2017 Year 01 Month 03 Day
Date trial data considered complete
2017 Year 01 Month 09 Day
Date analysis concluded
2017 Year 01 Month 15 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2017 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.