The Effectiveness of C2-C4 Compartment Block Versus Block of Costagliola, in the Control of Persistent Postoperative Pain in Patients Undergoing Carotid Thromboendarterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- somatic pain
研究概览
简要总结
C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy
详细描述
A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block group of the C2-C4 compartment ) and the control group B (block group according to Costagliola), during the 3 months after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing to carotid thromboendarterectomy
排除标准
- •ASA status: 4
- •pregnancy
- •BMI > 39,99
- •neurological impairment
- •neck anatomical abnormalities
- •status of sepsis
- •coagulopathy
- •neck cancer
- •neck infections
研究组 & 干预措施
C2-C4 compartment block
Experimental: the C2-C4 compartment anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenous muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.
干预措施: C2-C4 compartment anesthetic block (Procedure)
Costagliola block
Active Comparator: the Costagliola anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL injected in the posterior margin of the sternocleidomastoid muscle and along the anterior border of the same muscle.
干预措施: Costagliola block (Procedure)
结局指标
主要结局
somatic pain
时间窗: 3 mounths after surgery
Somatic pain assessed by Numeric Pain Rating Scale for pain (the 11-point numeric scale ranges from '0' representing "no pain" to '10' representing the "worst pain imaginable"
次要结局
- Neuropathic pain(3 months)
- Opiates request(3 mounths after surgery)
- Pregabalin request(3 months)
研究者
Emiliano Petrucci
Medical Doctor
San Salvatore Hospital of L'Aquila