Lidocaine Infusion for Pain After Herniotomy (LIPAH), A Randomized Placebo-controlled Trial (LIPAH Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Occurrence of chronic pain
研究概览
简要总结
This study seeks to investigate lidocaine infusion to reduce occurrence of chronic postoperative pain at 3-month after inguinal herniotomy
详细描述
Inguinal hernia repair is associated with a 5%-30% incidence of chronic pain; however, the pathogenesis remains unknown, and few studies have assessed chronic pain as the primary aim of the study. Lidocaine infusion could be a possible approach to reducing the prevalence of chronic pain after herniotomy. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after inguinal herniotomy would lower the incidence of chronic postoperative pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo unilateral inguino herniotomy
排除标准
- •(1)ASA classification status III or above
- •(2)Body weight<35kg
- •(3)Liver cirrhosis
- •(4)A history of previous herniotomy
- •(5)Pregnancy
- •(6)Severe arrhythmia
- •(7)Congestive heart failure
- •(8)Opioid or steroid use 6 months before surgery
- •(9)Allergy to lidocaine
- •(10)Chronic pain syndrome (any type)
- •(11)Emergency surgery
- •(12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders
研究组 & 干预措施
Lidocaine
Lidocaine treatment
干预措施: Lidocaine (Drug)
Control
Placebo treatment
干预措施: Control (Drug)
结局指标
主要结局
Occurrence of chronic pain
时间窗: At 3 months after surgery.
Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.
次要结局
- Postoperative nausea and vomiting (PONV)(Up to 48 hours after surgery)
- Postoperative acute pain(Up to 48 hours after surgery)
- Sedation(Up to 48 hours after surgery)
- Fatigue(Up to 48 hours after surgery)
- Chronic pain at 6-month after surgery(At 6 months after surgery.)
- Chronic pain at 12-month after surgery(At 12 months after surgery.)
研究者
Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain
Professor
Guangzhou First People's Hospital