Effects of Different Doses of Intravenous Lidocaine Infusion on Peri-operative Pain and Incidence of Postoperative Chronic Pain Within ERAS Protocols, a Dose Finding Study.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Total Intraoperative opioid consumption (Fentanyl)
研究概览
简要总结
This study aimed To investigate the effects of different doses of Intraoperative intravenous lidocaine infusion on intraoperative opioid consumption, perioperative pain control and incidence of postoperative chronic pain.
详细描述
Enhanced recovery after surgery (ERAS) protocols or fast track surgery are a number of interventions which are carried out in the perioperative period. They are aimed to decrease the harmful effects of surgery on the body and help the patient recover better after surgery. ERAS has been shown to reduce the length of hospital stay, overall hospital costs, opioid consumption in the perioperative period and to reduce complication rates.
One of the most important components of ERAS is adequate perioperative pain control using a multi-modal analgesic approach to help decrease dependence on opioids and provide better recovery and less postoperative hospital stay. Also, the severity and duration of acute postoperative pain is one of the predictors of chronic postsurgical pain (CPSP). Neuroplasticity (spinal sensitization) following the trauma of surgery can transform an acute pain to chronic pain if not treated effectively by aggressive management of acute pain.
Lidocaine (or 2-(diethylamino)-N-(2.6-dimethylphenyl) acetamide) is the main prototype of amino-amide local anesthetics. It has analgesic, anti-hyperalgesic and anti-inflammatory properties, which enable its use as a general anesthetic adjuvant. It can reduce nociception, cardiovascular responses to surgical stress, postoperative pain, and analgesic requirements.
Accordingly, Lidocaine infusion can have a role in enhancing postoperative quality of recovery, decreasing incidence of chronic postoperative pain and even increasing overall survival in patients undergoing major surgeries like in pancreatectomy.
The Systemic effects of intravenous Lidocaine infusion depends on its plasma level which is affected by the rate and dose of administration, drug interactions and speed of metabolism and elimination. Around 90% of lidocaine undergoes hepatic metabolism (CYP3A4), with the production of active metabolites. During lidocaine continuous infusion, the accumulation of these metabolites may inhibit its biotransformation and might be involved in some cases of intoxication. The clearance rate of lidocaine is approximately 0.85 L/kg/h. Finally, lidocaine is eliminated by the kidney (10% of lidocaine is eliminated unchanged in the urine).
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)
盲法说明
Each patient will be assigned by a randomly computer generated number to one of the 3 groups and the group assignment will be put in a sealed envelope only accessible by the investigator responsible for preparing the drug syringes. The patient and data collectors will be blinded to the patient group allocation as well as the managing anesthiologists during the operation
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age between 18 and
- •Patients with ASA I and II status.
- •Patients undergoing open laparotomy surgeries (including open cholecystectomies).
排除标准
- •Patients unable to comprehend the informed consent.
- •Patients on long term pre-operative opioid regimens.
- •Patients with impairment in hepatic or renal functions.
- •Patients who are planned to receive any form of regional block for the surgery.
研究组 & 干预措施
Group A
Group A: Bolus 10 ml Syringe with Lidocaine 0.5% (2.5 ml lidocaine 2% + 7.5 ml N.S), and infusion 50 ml Syringe with Lidocaine 0.5% (12.5 ml Lidocaine 2% + 37.5 ml N.S).
干预措施: Lidocaine IV (Drug)
Group B
Group B: Bolus 10 ml Syringe with Lidocaine 1% (5 ml lidocaine 2% + 5 ml N.S), and infusion 50 ml Syringe with Lidocaine 1% (25 ml Lidocaine 2% + 25 ml N.S).
干预措施: Lidocaine IV (Drug)
Group C
Group C: Bolus 10 ml Syringe with plain Lidocaine 2%, and infusion 50 ml Syringe with plain Lidocaine 2%.
干预措施: Lidocaine IV (Drug)
结局指标
主要结局
Total Intraoperative opioid consumption (Fentanyl)
时间窗: Every five minutes
Fentanyl doses of 0.5 mic/kg will be given when there is increase in hemodynamics by 20% of baseline and this will be reported
次要结局
- Time of first rescue analgesia used in the first 24 hours postoperative(Every one hour postoperative for 24 hours)
- Incidence of side effects related to Lidocaine infusion during the first 24 hours postoperative.(Every one hour postoperative for 24 hours)
- Total opioid consumption (Morphine) in the first 24 hours postoperative.(Every one hour postoperative for 24 hours)
- Incidence of chronic postoperative pain 2 months after the surgery.(Every week for 2 months postoperative.)
研究者
Omnia Yahia El Sayed Kamel
Lecturer of anesthesiology and surgical ICU and pain management
Cairo University