The Effect of Preemptive Oral Pregabalin as an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. A Randomized, Prospective, Double Blind Study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total postoperative oxycodone consumption
研究概览
简要总结
The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability.
The participants will be divided into 2 groups: with or without preemptive pregabalin administration.
详细描述
Pregabalin is a GABA analogue that has analgesic, anxiolytic and effects. There are studies indicating that this drug can be used as an element of multimodal analgesia to decrease opioid requirements in postoperative period. Such an effect would be particularly beneficial for patients with obesity scheduled for laparoscopic sleeve gastrectomy, most commonly performed bariatric surgery.
The investigators hypothesized that preemptive pregabalin administration may improve quality of postoperative pain score with less incidence of opioid side effects as well as similar or better intraoperative hemodynamical stability.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
- •Written informed consent
排除标准
- •Patient's refusal
- •Known allergies to study medication
- •Inability to comprehend or participate In pain scoring scale
- •Inability to use intravenous patient controlled analgesia
- •Changes of operation extent during procedure
- •Revisional operations
- •End stage organ failure
研究组 & 干预措施
Multimodal analgesia group
Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.
干预措施: Placebo (Drug)
Multimodal analgesia with preemptive pregabalin group
Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.
干预措施: Pregabalin 150mg (Drug)
结局指标
主要结局
Total postoperative oxycodone consumption
时间窗: Day "0"
PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes
Postoperative pain score in NRS scale
时间窗: Day "0", assessed 24 hour after operation
NRS range from 0 for no pain to 10 for worst pain imaginable
次要结局
- Lowest BP(intraoperative)
- Highest HR(intraoperative)
- Blurred vision(Day "0", assessed 1,6,12 and 24 hours after operation)
- Postoperative sedation score(Day "0", assessed 1,6,12 and 24 hours after operation)
- Postoperative oxycodone consumption(Day "0", assessed 1,6,12 and 24 hours after operation)
- Postoperative nausea and vomiting(Day "0", assessed 1,6,12 and 24 hours after operation)
- Highest BP(intraoperative)
- Lowest HR(intraoperative)
- Postoperative desaturation(Day "0", assessed 1,6,12 and 24 hours after operation)
- Total ephedrine dosis(intraoperative)
- Patient's comfort assessed in QoR-40 formulary(Day "0", assessed 24 hours after operation)