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IRCT20190611043861N1 IRCT 2019-07-02 Kerman University of Medical Sciences Comparison of Superficial Cervical Plexus Block Methods on the Severity of Pain After Thyroidectomy Comparison of the Effectiveness of Superficial Cervical Plexus Block (SCPB) under Ultrasound-Guided and via Landmark-Based on Severity of Pain After Thyroidectomy 2019-06-22 anticipated 102 Complete https://irct.ir/trial/40150 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Thyroidectomy, Superficial Cervical Plexus Block. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All of the data can be shared after unidentifiable people. When: Start the access period 6 months after publishing the results To whom: Only for researchers working in academic and scientific institutions Conditions: 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. Where to obtain: Sadra Samadi How to obtain: 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. Comments:
public Sadra Samadi
No. 1, Sarjangaldari Phase 1, Jomhouri Eslami Blvd
Kerman Iran (Islamic Republic of) 7618747319 +98 34 3211 4007 s.samadi@kmu.ac.ir Kerman University of Medical Sciences scientific Morteza Hashemian
Shafa crossroad, Jomhouri Eslami Blvd
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3211 3012 mortezahashemian@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) All Patients Candidates for Thyroidectomy Referred to Shahid Bahonar Hospital in Kerman, 2019 18 years 65 years Both 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 D34 Benign neoplasm of thyroid gland Rehabilitation Rehabilitation 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. 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. 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. Total Postoperative Prescribed Opioid. Timepoint: First 24 Hours Post Operation. Method of measurement: Nursery Records. Total prescribed opioids during surgery. Timepoint: From beginning of surgery until the completion. Method of measurement: Anesthesia records. Kerman University of Medical Sciences Approved 2019-05-25 Ethics committee of Kerman University of Medical Sciences Someyah crossroad, Beginning of Jahad Blvd, Beginning of Ibn Sina Street, In Front of Besat Clinic Kerman Kerman Iran (Islamic Republic of)