Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

Study Overview
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Brief Summary
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Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients. a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant, sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity and has recently been used to treat musculoskeletal pain conditions. Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary advancement to improve success and safety of regional anesthesia. Analgesic effect of US guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has not been reported yet. The aim of this study was to evaluate the analgesic effect of preemptive oral single dose tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores, analgesic consumption, analgesic related side effects.

Official Title
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Preemptive Single Dose Tizanidine and Ultrasound Guided Superficial Cervical Block on Pain After Thyroidectomy

Conditions
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Thyroidectomy

Intervention / Treatment
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* Drug: Placebo
* Drug: Tizanidine
* Drug: Bupivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients undergoing thyroidectomy Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications recurrent goiter emergency cases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Group Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side | Drug: Placebo<br>* Group Placebo: will receive a placebo pill 1 hour before surgery<br>* Other names: Placebo pill;Drug: Saline<br>* USG guided SCPB with saline bilaterally 10 ml each side<br>* Other names: Saline block;|
| Experimental: Tizanidine<br>Group Tizanidine (Group T) will receive 6 mg tizanidine 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side | Drug: Tizanidine<br>* Group T: 6 mg tizanidine1 hour before surgery<br>* Other names: Sirdalud MR;Drug: Bupivacaine<br>* Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side<br>|
| Active Comparator: Bupivacaine<br>Group Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side | Drug: Placebo<br>* Group Placebo: will receive a placebo pill 1 hour before surgery<br>* Other names: Placebo pill;Drug: Bupivacaine<br>* Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively. | postoperative first hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively. | postoperative second hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively. | postoperative 4th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively. | postoperative 8th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively. | postoperative 12th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively. | postoperative 24th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption |  | First 24 hours total opioid consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroidectomy pain, Tizanidine, Postoperative analgesia, Ultrasound guided Superficial cervical plexus block