Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative pain score at rest
研究概览
简要总结
Postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. If it remains undetected and untreated, it can result in increased perioperative morbidity and mortality.Thus, an increased interest in the use of non-opioid analgesic adjuncts has been prompted.
Intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory, anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (ERAS) profile. Its postoperative analgesia may last after reduction of its plasma concentration. So, lidocaine could be a good alternative in bariatric surgery.
Lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese patients. Also, its use in bariatric surgery showed a decrease in postoperative opioid use and improvement in the quality of recovery.
详细描述
compare the postoperative analgesic effect of intraoperative lidocaine infusion (Study group) used as a sole analgesic agent, to the intraoperative intravenous morphine (Control group) in laparoscopic gastric bypass surgery.
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, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •ASA physical status I- II
- •body mass index (BMI) ˃ 35
- •scheduled to undergo laparoscopic gastric bypass
排除标准
- •Patients' refusal
- •hypersensitivity to the study medications
- •patients with known history of; hepatic disease, renal dysfunction
- •severe renal impairment (eGFR <30ml/min/1.73m2)
- •heart failure; left ventricular ejection fraction than 35%
- •any cardiac dysrhythmias; Adam-Stokes syndrome; Wolff- Parkinson-White syndrome, atrio-ventricular block with heart rate below 50 bpm
- •chronic pain
- •concomitantly taking beta blocking drugs •substance abuse disorder
- •chronic opioid use.
研究组 & 干预措施
Group Lidocaine
At induction of anesthesia, patients will receive a loading dose of intravenous (IV) 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% via infusion pump. The infusion will be continued till the end of surgery.
干预措施: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE] (Drug)
Group Morphine
At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery
干预措施: morphine sulphate (10mg/ ml ampoule) (Drug)
结局指标
主要结局
Post-operative pain score at rest
时间窗: 1hour
Intensity of pain will be monitored ; on arrival to the PACU, at 20, 40 and 60 minutes after arrival to the PACU by the Numeric Pain Rating Scale. The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which the patient selects a whole number (0-10 integers) that best reflects the intensity of pain felt.Where 0 is no pain felt and 10 is the worst pain.
次要结局
- mean values of mean blood pressure (MBP)(5 hours)
- Post-operative nausea and/or vomiting(1 hour)
- Post-operative sedation score(1 hour)
- Modified Aldrete Score(1 hour)
- Duration of surgery(3 hours)
- Duration of anesthesia(4 hours)
- sPO2(5 hours)
- Respiratory rate(5 hours)
- mean values of heart rate (HR)(5 hours)
- Number of patients requiring postoperative additional morphine doses(1 hour)
- the total dose of morphine given to each patient(5 hours)
- Number of patients requiring intra-operative morphine(4hours)
研究者
Ghada M.Samir
Assistant Professor of Anesthesia, Intensive care and Pain Management
Ain Shams University