UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035497 |
|---|---|
| Receipt number | 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 | 2021/01/10 20:32:15 |
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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 | Alaaeldin |
| Middle name | |
| Last name | ELDEEB |
Organization
Mansoura university
Division name
anesthesia department
Zip code
00966
Address
king fahed road
TEL
01225303563
alaaeldeep9@hotmail.com
Public contact
Name of contact person
| 1st name | Alaaeldin |
| Middle name | |
| Last name | ELDEEB |
Organization
Dr.
Division name
anesthesia department
Zip code
00966
Address
king fahed road
TEL
+2050226261
Homepage URL
alaaeldeep9@hotmail.com
Sponsor or person
Institute
Mansoura university
Institute
Department
Personal name
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
Mansoura Faculty of Medicine Institutional Research Board (MFM-IRB)
Address
Mansoura egypt
Tel
+20 109 212 7930
irb.mfm@hotmail.com
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
http://www.roaic.eg.net/article.asp?issn=2356-9115;year=2019;volume=6;issue=4;spage=418;epage=423;au
Publication of results
Published
Result
URL related to results and publications
http://www.roaic.eg.net/article.asp?issn=2356-9115;year=2019;volume=6;issue=4;spage=418;epage=423;au
Number of participants that the trial has enrolled
40
Results
after applying the exclusion criteria, forty patients were randomized into two groups in this study. The postanesthesia care unit time, pain score for eight hours postoperatively, postoperative opioid requirement, and hospital stay were statistically significantly less in the second group than in the control group. Patient satisfaction is more observed in the second group.
Results date posted
| 2021 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The postanesthesia care unit time, pain score for8hours postoperatively, postoperative opioid requirement, and hospital stay were statistically significantly less in the second group than in the control group. Patient satisfaction is more observed in the second group.
Participant flow
summary results within 12 months of the date on which the final data were collected will be submitted.
Adverse events
no adverse effects
Outcome measures
The postanesthesia care unit time, pain score for8 hours postoperatively, postoperative opioid requirement, and hospital stay were statistically significantly less in the second group than in the control group. Patient satisfaction is more observed in the second group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 06 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 07 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040446
