Comparison of Erector Spinae Plane Block and Intravenous Lidocaine for Chronic Pain Post Mastectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Item 5 of Brief Pain inventory score (BPI Score)
研究概览
简要总结
Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).
For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.
Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery.
详细描述
Patients undergoing breast surgery with lymph node dissection were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).
For Lido-IV group, patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery.
For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction with injection of 30 ml of Ropivacaine 3.75%.
For both group, persistant pain post mastectomy was assessed by Item 5 of BPI score at 1, 3 and 6 months post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •patients aged 18 and older
- •American Society of anesthesiologists classification I or II
- •patients proposed for planned mastectomy with axillary lymph node dissection.
- •hemodynamic stability.
排除标准
- •patient refusal
- •male gender
- •history of major surgery within the year.
- •allergy to local anesthetics
- •hemodynamic instability
- •Patients on long-term analgesics
- •Severe heart and/or kidney damage
- •neurological/psychiatric impairment
研究组 & 干预措施
Lidocaine-IV
Intravenous Lidocaine dose loading than continuous infusion
干预措施: Lido-IV (Drug)
Erector spinae Block
An ultrasound guided Erector Spinae Block is performed with injection of 30 ml of Ropivacaine 3.75%
干预措施: ESP Block (Drug)
结局指标
主要结局
Item 5 of Brief Pain inventory score (BPI Score)
时间窗: item 5 of the BPI score evaluated as follows: 0 minimum score and 10 maximum score, at 01, 03 and 06 months post surgery
Note of Brief Pain inventory Scale (BPI Score)
次要结局
- Acute pain assessed by Simple Verbal Scale (SVS)(Postoperatively, at Hour 2, Hour 12 and Hour 24)
- Postoperative nausea and vomiting(During the first 24hours postoperatively)
- Hospital length of stay(From the end of the surgery to discharge from the hospital)
- DN4 questionnaire (DN4)(DN4 represented by 10 items with a score from a minimum of 0 to a maximum of 10, at 03 and 06 months post surgery)
- The short-form McGill Pain Questionnaire (SFM-PQ)(the 15 items are rated on a four-point pain intensity scale, at 01, 03 and 06 months after surgery)
研究者
HibetAllah Ktata
Associate Professor
University Tunis El Manar