UMIN-CTR Clinical Trial

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
Email	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
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	Mansoura Faculty of Medicine Institutional Research Board (MFM-IRB)
Address	Mansoura egypt
Tel	+20 109 212 7930
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040446