UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032649 |
|---|---|
| Receipt number | R000037228 |
| Scientific Title | 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 | 2019/05/21 16:51:17 |
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Basic information
Public title
Ultrasound guided-modified approach local/regional anesthesia for thyroidectomy. A randomized controlled study.
Acronym
Ultrasound guided-modified approach local/regional anesthesia for thyroidectomy.
Scientific Title
Ultrasound guided-modified approach local/regional anesthesia for thyroidectomy. A randomized controlled study.
Scientific Title:Acronym
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
| 1st name | alaa |
| Middle name | |
| Last name | eldeeb |
Organization
Mansoura university
Division name
Anesthesia department
Zip code
002
Address
samia elgamal
TEL
0020502226261
alaaeldeep@gmail.com
Public contact
Name of contact person
| 1st name | alaa |
| Middle name | |
| Last name | eldeeb |
Organization
Mansoura university
Division name
anesthesia department
Zip code
002
Address
samia
TEL
0020502226261
Homepage URL
alaaeldeep@gmail.com
Sponsor or person
Institute
Egypt, mansoura university, mansoura university hospitals
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
IRB faculty of medicine
Address
Egypt,mansoura university
Tel
+201002421140
menhag@mans.edu.eg
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
71
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 12 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 20 | Day |
Last modified on
| 2019 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037228
