NCT03109691

Brief Summary

Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

January 28, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 16, 2020

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

March 30, 2017

Last Update Submit

March 13, 2020

Conditions

Bilateral Superficial Cervical Block

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    visual analoge scale (VAS)

    through first 24 h postoperative.

Secondary Outcomes (4)

  • HEART RATE

    5,10,15,30,60,90,120 min introperative

  • postoperative nausea, vomiting

    through first 24h postoperative

  • The time period for the first analgesic requirement

    through first 24h postoperative

  • blood pressure

    5,10,15,30,60,90,120 min intraoperative

Study Arms (2)

group 1

ACTIVE COMPARATOR

30 patients will receive bupivacaine

Drug: bupivacaineDrug: DexamethasoneDevice: ultrasound

group 2

ACTIVE COMPARATOR

30 patients will receive bupivacaine and Dexamethasone. .

Drug: bupivacaineDevice: ultrasound

Interventions

bupivacaineDRUG

group 1

group 1group 2
DexamethasoneDRUG

group 2

group 1
ultrasoundDEVICE

in all groups

group 1group 2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) class I and II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

BupivacaineDexamethasoneUltrasonography

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

mohmed Bakri, prof

CONTACT

+20882413201mhbakri@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 12, 2017

Study Start

January 28, 2018

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

March 16, 2020

Record last verified: 2019-06

Locations

EG(1)