Preemptive Single Dose Tizanidine and Ultrasound Guided Superficial Cervical Block on Pain After Thyroidectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analog pain score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist's physiologic state I-III patients undergoing thyroidectomy
排除标准
- •chronic pain
- •bleeding disorders
- •renal or hepatic insufficiency
- •patients on chronic non-steroidal anti-inflammatory medications
- •recurrent goiter
- •emergency cases
研究组 & 干预措施
Placebo
Group Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side
干预措施: Placebo (Drug)
Placebo
Group Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side
干预措施: Saline (Drug)
Tizanidine
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
干预措施: Tizanidine (Drug)
Tizanidine
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
干预措施: Bupivacaine (Drug)
Bupivacaine
Group Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side
干预措施: Placebo (Drug)
Bupivacaine
Group Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Visual analog pain score
时间窗: postoperative 24th hour
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.
次要结局
- Opioid consumption(First 24 hours total opioid consumption)