The Effect of Perioperative Systemic Lidocaine on Quality of Recovery After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 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
When given intravenously, the local anesthetic lidocaine has been shown to decrease the amount of pain medication patients require when recovering from several types of surgeries. Cesarean delivery is a very common surgery in the United States, effecting more than 1 million women each year. The investigators hypothesize that lidocaine, given during and immediately after a patient undergoes a cesarean section, will help improve a mother's overall recovery experience, as well as positively influence bonding with her new baby.
详细描述
Pain after Cesarean delivery is a common occurrence on the labor and delivery unit. The increased use of neuraxial anesthesia has allowed the administration of neuraxial opioids to help with postoperative pain control. Many patients, however, still require IV and oral opioids in the post anesthesia recovery unit (PACU), and on the postpartum nursing floor. Post Cesarean delivery pain not only has the usual adverse effects common to all postoperative pain (i.e. increased risk for deep vein thrombosis, pulmonary embolism, coronary ischemia, pneumonia, poor wound healing, and psychological dysfunction) but also has the potential to adversely affect mother-baby bonding, time spent in skin-to-skin contact and success of initiating effective breastfeeding.
Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when given by a low-dose infusion.
Assessing a patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to her normal activities and effectively care for her newborn is one of the most important signs of a successful surgical procedure, and it has significant economic, sociological and psychological implications.
Quality of recovery -40(QoR-40) is a validated 40-item instrument to assess the quality of post-operative recovery (10). Myles et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument.
This study will evaluate the effect of perioperative systemic lidocaine in the postoperative quality of recovery of patients undergoing Cesarean delivery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Class II
- •English speaking
- •Scheduled Cesarean delivery
排除标准
- •Allergy to local anesthetics
- •Chronic opioid use
- •Greater than 2 prior cesarean deliveries
- •Prior myomectomy
- •Prior classical cesarean incision
- •BMI greater than 40
- •History of cardiac disease
研究组 & 干预措施
Lidocaine
Intravenous lidocaine 1.5 mg/Kg bolus dose and 2mg/Kg/hr infusion
干预措施: Lidocaine (Drug)
Normal Saline
Intravenous 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: 1 day
The quality of recovery 40 (QoR-40) is a validated questionnaire used to assess several variables that effect a patient's post-operative experience.
次要结局
- Opioid consumption(1 day)
- Skin-to-skin time(1 day)
研究者
Jason Farrer
Clinical Instructor
Northwestern University