UMIN-ICDS 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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040446


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name