The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Quality of Recovery 40 on the Day After Surgery
研究概览
简要总结
Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery.
This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I, II,III;
- •BMI > 35 kg/m2,
- •Age between 18-70,
- •Fluent in English,
- •Patients undergoing laparoscopic gastric bypass,
- •EKG within 3 months.
排除标准
- •History of allergy to local anesthetics,
- •History of chronic opioid use,
- •Pregnant patients,
- •History of EKG abnormalities.
- •Dropout: Conversion to open, patient or surgeon request.
研究组 & 干预措施
Lidocaine
Lidocaine infusion
干预措施: Lidocaine Infusion (Drug)
Placebo
Placebo Normal Saline Infusion
干预措施: Normal Saline (Drug)
结局指标
主要结局
Quality of Recovery 40 on the Day After Surgery
时间窗: 24 hours
Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high. The minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.
次要结局
- 24 Hour Total Opioid Consumption(24 hours post surgery)
研究者
Gildasio De Oliveira
Gildasio De Oliveira, M.D. Principal Investigator
Northwestern University