Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery: Prospective, Randomized, Double-blinded, Placebo Controlled, Mono-Center Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Postoperative VAS/NRS Score
研究概览
简要总结
The investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine group" and a "Control group".
The primary outcome will be the proportion of patients suffering from higher pain intensity within the first four hours after bariatric surgery.
Secondary outcomes include the average maximal pain intensity during first four hours and during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting, time to first defecation and total time spent in hospital.
详细描述
Postoperative pain is a common problem in today's surgery, although pain management techniques have improved in the last years. Systemic application of lidocaine has gained interest since several studies have shown its analgesic, anti-inflammatory and antihyperalgesic properties. In this clinical trial the analgesic effect of intravenously administrated lidocaine is compared with placebo. Despite longstanding use as an antiarrhythmic agent and its use in many clinical trial as analgesic, lidocaine is not licensed for this indication and application. Current studies, setting the focus on abdominal surgery, indicated that the systemic application of lidocaine was associated with fewer intensity of pain at rest and during mobilization and resulted in a decrease of patients'opiate consumption.
The intervention to be studied will either be the additional application of systemic lidocaine 1% to general anesthesia in bariatric surgery or the application of placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. The population to be studied will include 140 patients listed for bariatric surgery at the Kantonsspital St. Gallen. Patients, medical practitioner, nurses and investigators will be blinded. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Measures taken to minimize or avoid bias include randomization and blinding of participants after they have given their informed consent. Blinding of medical practitioner and medical personnel will be conducted by provision of equal looking and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective laparoscopic bariatric surgery
- •ASA classification I - III
- •age 18 - 80
- •given informed consent
排除标准
- •no written consent
- •allergy to the investigational product
- •cardiac arrhythmia (pacemaker)
- •liver dysfunction (Child-Pugh classification A, B or C)
- •pregnancy
- •central nervous disease
- •chronic pain and pre-existing opiate prescription
- •expected non-compliance
- •drug/alcohol abuse
研究组 & 干预措施
Lidocaine Hydrochloride
- 1.5 mg/kg lean body mass lidocaine (lidocaine 1%) bolus I.V. as general anesthesia steady state concentration is accomplished
- 1.5 mg/kg lean body mass/h lidocaine I.V. with beginning of surgical procedures
- after completion of surgery: transfer to PACU, pain evaluation for 48 hours
- duration of intervention: lidocaine infusion up to four hours from completion of surgery, or till transfer to surgical ward
干预措施: Lidocaine Hydrochloride (Drug)
Saline Solution
- 0.15 ml/kg lean body mass saline 0.9% bolus I.V. as general anesthesia steady state concentration is accomplished
- 0.15 ml/kg lean body mass/h saline 0.9% I.V. with beginning of surgical procedure
- after completion of surgery: transfer to PACU, pain evaluation for 48 hours
- duration of intervention: saline infusion up to four hours from completion of surgery, or till transfer to surgical ward
干预措施: Saline Solution (Drug)
结局指标
主要结局
Postoperative VAS/NRS Score
时间窗: 0 - 4 hours after surgery
Any development of VAS/NRS score \> 3 (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as "no pain" to 10 points as "severe pain") , in hourly measurements within the first four hours after completion of bariatric surgery to evaluate the pain experienced by patients after the surgical intervention
次要结局
- Time to first Defecation(0 - 48 hours after surgery)
- Duration of Hospitalization(0 - 48 hours after surgery)
- Total Amount of Opiate Consumption(0 - 48 hours after surgery)
- Average experienced maximal pain during the first four hours and 48 hours after Surgery(0 - 48 hours after surgery)
- Occurence of Postoperative Nausea and Vomiting after Surgery(0 - 48 hours after surgery)
研究者
Miodrag Filipovic, Prof. Dr. med.
Deputy Head of the Clinic for Anesthesiology and Intensive Care
Cantonal Hospital of St. Gallen