- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03109691
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
-
-
-
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
|
group 1
group 2
in all groups
|
Active Comparator: group 2
30 patients will receive bupivacaine and Dexamethasone. .
|
group 1
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
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
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Anesthetics, Local
- Dexamethasone
- Bupivacaine
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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