Ultrasound Guided Bilateral Superficial Cervical Block fo... | NCT03109691

Studies
Ultrasound Guided Bilateral Superficial Cervical Block for Post-operative Pain Therapy in Thyroid Surgery

NCT03109691

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 16, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Bilateral Superficial Cervical Block

Interventions

bupivacaine
Dexamethasone
ultrasound

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 28, 2018Actual

Primary Completion Date

Jul 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Mar 30, 2017

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2020

Last Update Posted Date

Mar 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Active Comparator	30 patients will receive bupivacaine	Drug: bupivacaine Drug: Dexamethasone Device: ultrasound
group 2	Active Comparator	30 patients will receive bupivacaine and Dexamethasone. .	Drug: bupivacaine Device: ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine	Drug	group 1	group 1 group 2
Dexamethasone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale	visual analoge scale (VAS)	through first 24 h postoperative.

Secondary Outcomes

Measure	Description	Time Frame
HEART RATE	heart rate( beats per minute)	5,10,15,30,60,90,120 min introperative
postoperative nausea, vomiting	postoperative nausea, vomiting was recorded

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) class I and II

Exclusion Criteria:

allergy to local anesthetics, bleeding diatheses, and local infection or sepsis thyrotoxicosis and , malignancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohmed Bakri, prof	Contact	+20882413201		mhbakri@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital	Recruiting	Asyut		71515	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D003907	Dexamethasone
D014463	Ultrasonography

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided