- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680353
The Perioperative Analgesic Efficiency of Bilateral Superficial Cervical Plexus Block in Patients With Thyroidectomy
April 18, 2017 updated by: Hakan Tapar, Tokat Gaziosmanpasa University
To determine the postoperative analgesic efficiency of bilateral superficial plexus block, patients are divided into two groups.
Study group received bilateral superficial plexus block, where control had none.
Visual analog scale, opioid consumption and presence of nausea-vomiting are recorded.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bilateral superficial cervical plexus block has successfully been demonstrated to provide an efficient analgesia in patients with thyroidectomy, parathyroidectomy, carotis end-arterectomy.
The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of bilateral superficial cervical plexus block in patients with total thyroidectomy.
After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire.
Patients are divided into two groups by computer-based randomization technique as control and study group.
After standard monitorization, anesthesia induction and tracheal intubation, bilateral superficial cervical plexus block is performed to study group and no intervention to control group.
At the end of the operation all patients received paracetamol 1 gr intravenous.
In postoperative period, visual analog scale values, opioid consumption, presence of nausea-vomiting, anti-emetic usage or any other complications are recorded.
Study Type
Interventional
Enrollment (Actual)
47
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
-
-
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Tokat, Turkey, 60200
- Gaziosmanpasa University
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years of age
- Planned to undergo thyroidectomy
- An American Society of Anesthesiologists score of 1 or 2
Exclusion Criteria:
- Severe cardiovascular disease
- Psychiatric diseases
- Difficult intubation
- Rejected to participation
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Study group
Patients received bilateral superficial cervical plexus block before operation
|
A kind of anesthetic nerve block type performed to block the nerve function temporarily by administrating local anesthetics through the trajectory of the nerve.
|
|
No Intervention: Control group
Patients received no intervention before operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual analog scale
Time Frame: one time in postoperative period for one year
|
one time in postoperative period for one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Presence of nausea-vomiting
Time Frame: In postoperative period for one year
|
In postoperative period for one year
|
|
Mean arterial pressure
Time Frame: In both intraoperative and postoperative period for one year
|
In both intraoperative and postoperative period for one year
|
|
Heart rate
Time Frame: In both intraoperative and postoperative period for one year
|
In both intraoperative and postoperative period for one year
|
|
Antiemetic usage
Time Frame: postoperative period for one year
|
postoperative period for one year
|
|
respiratory rate
Time Frame: postoperative period for one year
|
postoperative period for one year
|
|
opioid consumption
Time Frame: During postoperative period for one year
|
During postoperative period for one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hakan Tapar, Assist.Prof, Gaziosmanpasa 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)
April 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
February 10, 2016
First Posted (Estimate)
February 11, 2016
Study Record Updates
Last Update Posted (Actual)
April 19, 2017
Last Update Submitted That Met QC Criteria
April 18, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 15-KAEK-055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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