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

March 13, 2020 updated by: Eman A. Ismail, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
30 patients will receive bupivacaine
Drug: bupivacaine
group 1
Drug: Dexamethasone
group 2
Device: ultrasound
in all groups
Active Comparator: group 2
30 patients will receive bupivacaine and Dexamethasone. .
Drug: bupivacaine
group 1
Device: ultrasound
in all groups

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HEART RATE
Time Frame: 5,10,15,30,60,90,120 min introperative
heart rate( beats per minute)
5,10,15,30,60,90,120 min introperative
postoperative nausea, vomiting
Time Frame: through first 24h postoperative
postoperative nausea, vomiting was recorded
through first 24h postoperative
The time period for the first analgesic requirement
Time Frame: through first 24h postoperative
total dose
through first 24h postoperative
blood pressure
Time Frame: 5,10,15,30,60,90,120 min intraoperative
blood pressure (mm Hg)
5,10,15,30,60,90,120 min intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01003060468

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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