Effect of perioperative duloxetine on postoperative quality of recovery and analgesia after thoracolumbar spine surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post operative QoR score at 48 hours
研究概览
简要总结
A total number of 70 patients undergoing thoracolumbar spinal surgery will be randomly allocated to two groups of 35 patients each using computer generated random table and allotted number will be secured in a coded opaque sealed envelope. The patients will be allocated to one of the following two groups:
Group D( n=35): Patients will receive duloxetine 60mg orally 2 hours before surgery and another tablet after 24 hours in the next morning.
Group C (n=35); Patients will receive identical placebo orally 2 hours before surgery and another tablet after 24 hours in the next morning.
Procedure on day of surgery:
Patient will be shifted to the operation room. Monitoring of heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, continuous electrocardiogram, respiratory rate and oxygen saturation will be done. Baseline vitals will be noted. All the patients will receive a standardised general anaesthesia using propofol 2mg/kg as inducing agent and vecuronium 0.1 mg/kg as muscle relaxant. Anaesthesia will be maintained by N2O/O2 in ratio 60:40 with sevoflurane. The surgery will proceed. Patient will be extubated after surgery and shifted to post anaesthesia care unit (PACU). Patients in both study groups will be connected to IV-PCA Pump (Micrel Rythmic TM evolution PCA) with 1mg/ml morphine with a lockout interval of 5 minutes.
Patients vitals will be monitored intra and post operatively and observations will be recorded in the prescribed performa. Post operative QoR score at 48 hours, cumulative morphine consumption, VAS scores, time to first bolus of morphine, satisfaction scores and side effects will be assessed and filled in prescribed performa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between 18 and 65 years Patients undergoing thoracolumbar spine surgeries requiring single level pedicle screw fixation- without having any neurological deficit ASA Grade I or II Body mass index between 18 and 35.
排除标准
- •Patient’s refusal for consent History of drug abuse Severe cardiovascular, respiratory, neurological or metabolic disease Chronic analgesia use Patients having any drug allergy to duloxetine or morphine Inability of the patient to understand the QoR -15 questionnaire Inability to operate a Patient controlled analgesia (PCA) pump Inability of the patient to understand Visual Analogue Score.
结局指标
主要结局
Post operative QoR score at 48 hours
时间窗: It is assessed at 48 hours
次要结局
- Cumulative opioid consumption(It is assessed at 48 hours after surgery)
- Visual Analogue Scores assessment(It is done at 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and 48 hours after surgery)
- Patient satisfaction score by a 4 point verbal score(It is assessed at 48 hours after surgery)
- Side effects of drug if any experienced(It is done at 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and 48 hours after surgery)
研究者
Ashima
Government Medical College and Hospital, Chandigarh