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Comparison of the Effectiveness of Superficial Cervical Plexus Block (SCPB) under Ultrasound-Guided and via Landmark-Based on Severity of Pain After Thyroidectomy

Protocol summary

Study aim
The effect of the Superficial Cervical Plexus Block under ultrasound guide and through anatomical landmarks on the severity of pain after Thyroidectomy
Design
A triple blinded clinical trial with a control group and two intervention groups, randomized by Random Allocation software on 102 patients undergone thyroidectomy in 2019.
Settings and conduct
After selecting and grouping patients referred to Bahonar Hospital in Kerman for thyroidectomy, the using of the Visual Analogue Scale will be taught to them. Then, general anesthesia will be done. In two groups 1 and 2, a superficial cervical plexus block will be done with ultrasound-guided or anatomical landmarks. After surgery, the peer reviewer evaluates the pain severity by using the VAS every 3 to 24 hours. In this study, the patient, the pain assessor and data analyzer, would not be aware of the patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Ages 18 To 65 Years, ASA Classes 1 And 2, Informed Consent; Exclusion Criteria: A History Of The Previous Thyroid, Parathyroid Or Neck Surgery, Retrosternal Goiter, Thyroid Dysfunction, Body Mass Index Above 25, Coagulation Disorders, Bupivacaine Sensitivity, Short Neck, Pathology Of The Injection Site, Narcotic Addiction
Intervention groups
Group 1: Superficial cervical plexus block under ultrasound guidance. Group 2: Superficial cervical plexus block through anatomical landmarks. Group 3: Non superficial cervical plexus block
Main outcome variables
The pain severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190611043861N1
Registration date: 2019-07-02, 1398/04/11
Registration timing: registered_while_recruiting

Last update: 2019-07-02, 1398/04/11
Update count: 0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Sadra Samadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 4007
Email address
s.samadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Superficial Cervical Plexus Block (SCPB) under Ultrasound-Guided and via Landmark-Based on Severity of Pain After Thyroidectomy
Public title
Comparison of Superficial Cervical Plexus Block Methods on the Severity of Pain After Thyroidectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients Candidates for Thyroidectomy Referred to Shahid Bahonar Hospital in Kerman, 2019
Exclusion criteria:
Age under 18 years Age over 65 years History of previous thyroid or parathyroid and neck surgery Retrosternal Goiter Thyroid dysfunction Urgent surgery within the first 24 hours Body Mass Index More Than 25 Coagulation Abnormalities Allergy to Bupivacain ASA Class above 2 Short Neck Pathology of Incision Site Patient Refusal Opioid Addiction
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization method using "Random Allocation software" will be used. The sample size (102 people) and the number of groups (3 groups) are included in the software. Then, based on the software output, the patients after going to the hospital will be allocated in one of the three groups: block under Ultrasound-guided, via Landmark and control.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient is not aware of the grouping. After surgery, the pain assessor is not aware of the grouping. Data analyzer is not aware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Someyah crossroad, Beginning of Jahad Blvd, Beginning of Ibn Sina Street, In Front of Besat Clinic
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.KMU.REC.1398.135

Health conditions studied

1

Description of health condition studied
Thyroidectomy, Superficial Cervical Plexus Block
ICD-10 code
D34
ICD-10 code description
Benign neoplasm of thyroid gland

Primary outcomes

1

Description
Pain Score Based on Visual Analog Scale
Timepoint
Pain Severity Evaluation, Immediately Post Operation and 3, 6, 9, 12 and 24 Hours After Surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Total Postoperative Prescribed Opioid
Timepoint
First 24 Hours Post Operation
Method of measurement
Nursery Records

2

Description
Total prescribed opioids during surgery
Timepoint
From beginning of surgery until the completion
Method of measurement
Anesthesia records

Intervention groups

1

Description
First Intervention group: With the patient in supine position, the head turned slightly away from the side to be blocked. After prep the transducer is placed on the lateral neck, overlying the sternocleidomastoid muscle (SCM) at the level of its midpoint (approximately the level of the cricoid cartilage). Once the SCM is identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen. At this point, an attempt should be made to identify the brachial plexus and/or the interscalene groove between the anterior and middle scalene muscles. The plexus is visible as a small collection of hypoechoic nodules (honeycomb appearance) immediately underneath the prevertebral fascia that overlies the interscalene groove. Once identified, the needle is passed through the skin, platysma and prevertebral fascia, and the tip placed adjacent to the plexus. Following negative aspiration, 1 to 2 milliliter of Bupivacaine 0.25% is injected to confirm the proper injection site. Then the remainder of the local anesthetic (15 milliliters) is administered.
Category
Rehabilitation

2

Description
Second Intervention group: With the patient in supine position and the head turned slightly away from the side to be blocked, is asked to lift his or her head off of the bed to accentuate the sternocleidomastoid muscle. The needle insertion site is along the posterior border of the sternocleidomastoid. After prep three injections of 5 milliliters of Bupivacaine 0.25% are injected behind the posterior border of the sternocleidomastoid muscle subcutaneously, perpendicularly, cephalad, and caudad in a fan fashion.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Sadra Samadi
Street address
Shahid Bahonar Hospital, Qarani Street.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
samadi_sadra@yahoo.com
Web page address
http://www.kmu.ac.ir/fa/bh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Somayeh crossroad, at the Beginning of Ibn Sina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sadra Samadi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Sarjangaldari Phase 1, Jomhouri Eslami Blvd
City
Kerman
Province
Kerman
Postal code
7618747319
Phone
+98 34 3211 4007
Fax
Email
s.samadi@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shafa crossroad, Jomhouri Eslami Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 3012
Fax
+98 34 3211 3170
Email
mortezahashemian@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shafa crossroad, Jomhouri Eslami Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 3012
Fax
+98 34 3211 3170
Email
mortezahashemian@kmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any analysis of the data is allowed but not published. A written request with a valid letter from a University or scientific institution with an identification card is required.
From where data/document is obtainable
Sadra Samadi
What processes are involved for a request to access data/document
A written request will be submitted to the research Vice-chancellor of the Kerman University of Medical Sciences with a valid letter from the University or institute.
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