UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025343 |
|---|---|
| Receipt number | 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 18:17:46 |
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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
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
Elbahrawy_khaled@yahoo.com
Sponsor or person
Institute
Anesthesia department Mansoura university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029162
