Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Adult patients between the ages of 18-65 years old
- •BMI ≥ 40 kg/m2, ≤ 60 kg/m2
- •Undergoing a primary laparoscopic RYGB by Dr. Murr
- •Agree to be followed 24 hours postoperatively
- •Normal K+ and Mg++ serum levels
排除标准
- •BMI less than 40 kg/m2, > 60 kg/m2
- •Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
- •Allergy to lidocaine
- •Allergy to hydromorphone or ketorolac
- •Allergy to corn or amide anesthetics
- •Use of (thioridizine)
- •Pregnancy
- •Abnormalities of ALT or AST
- •Intra-operative diagnosis of cirrhosis or portal hypertension
- •Intraoperative complications per surgeon
- •Intraoperative extensive adhesions per surgeon
- •Chronic pain syndrome and chronic use of narcotics
- •Severe back pain secondary to degenerative joint disease
研究组 & 干预措施
Lidocaine
Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr
干预措施: Lidocaine (Drug)
Placebo
Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 24 hours post-surgery
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
次要结局
未报告次要终点