A Randomized, Double-blinded, Placebo-controlled Trial of the Effects of Infusing Local Anesthesia on Post-operative Pain During Laparoscopic Inguinal Hernia Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Lahey Clinic
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visual Analog Scale Pain Score Assessment (VAS)
研究概览
简要总结
To assess effect of local anesthetic into the preperitoneal space during laparoscopic hernia repair on post-operative 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older with unilateral or bilateral inguinal herna for laparoscopic repair
- •American Society of Anesthesiology (ASA) Class I and II
排除标准
- •Conversion from laparoscopic to open surgery
- •History of Chronic pain or ongoing treatment for chronic pain
- •Age less than 18 yrs
- •Allergy to local anesthetics
研究组 & 干预措施
anesthetic intervention
After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the treatment group will receive infusion of 15 cc 0.5% Bupivicaine.
干预措施: 0.5% Bupivicaine (Drug)
Saline intervention
After deployment of therapeutic mesh in the preperitoneal space of the abdomen wall during the procedure, the placebo group will receive the infusion of 15 cc 0.9% Saline.
干预措施: 0.5% Bupivicaine (Drug)
结局指标
主要结局
Visual Analog Scale Pain Score Assessment (VAS)
时间窗: Pain scale 3 days after surgery
Pain level recorded at 3 days after surgery. VAS scale measures pain in increments of whole numbers from 0 (no pain) to 10 (most sever pain imaginable)
次要结局
- Amount of Pain Medication Used in Oral Morphine Equivalents(4 hours after surgery)
- Duration of Narcotic Used to Control Pain(4 weeks post-op)
研究者
Dmitry Nepomnayshy
Study Coordinator sub- Investigator
Lahey Clinic