Randomized Controlled Trial of Regional Anesthesia in Combination With General Anesthesia for Thyroidectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- the incidence of chronic postsurgery pain
研究概览
简要总结
For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine whether it offers real benefits in terms of patient outcome from major surgery, compared with general anesthesia. Although it is clear that regional analgesia in association with general anesthesia substantially reduces postoperative pain, the benefits in terms of overall perioperative outcome are controversial. The aim of this study is to evaluate the effect on short and long-term postoperative outcomes of adding regional analgesia to general anaesthesia in thoridetomic patients.
详细描述
Patients who are divided into two treatment groups: (a) a bilateral superficial cervical plexus group (group S) and a control group (group C).We performe bilateral superficial cervical plexus block (BSCPB)with 0.25-0.75% ropivacaine10 ml to group S and 10ml NaCl 0.9% to group C. All BSCPB is performed by experienced anesthesia doctor after a standardized induction of general anaesthesia.eneral anaesthesia was induced by using intravenously with midazolam,propofol, fentanyl, cisatracurium is injected IV to facilitate orotracheal intubation. After a standardized induction of general anaesthesia, patients receive Regional Anesthesia at the discretion of the experienced anesthesiologist who was blinded to treatment.
The patient is placed in a supine position with the head turned away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle.
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
- Triple (Participant, 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
- •Eligible patients fit an ASA I or II classification adult patients who will be scheduled for elective thyroid lobectomy under general anaesthesia.
排除标准
- •hypersensitivity to any study drugs
- •Long-term use of anticoagulant drugs: warfarin or heparin
- •the neck or systemic infection
- •communication disorder
- •refuse to accept this research subjects.
研究组 & 干预措施
nerve block
cervical plexus block with ropivacaine
干预措施: nerve block (Procedure)
Placebo
placebo saline
干预措施: placebo (Procedure)
结局指标
主要结局
the incidence of chronic postsurgery pain
时间窗: 60 days
the time from the end of surgery
次要结局
- hemodynamic stability(1 day)
- postoperative nausea and vomiting(2 days after operation)
- the intensity of acute pain(24 hours)
研究者
Xiangcai Ruan
Vice chair
Guangzhou First People's Hospital