Quality of Recovery (q0R 15) following administration of intravenous vs epidural opioids and non opioids in oncological abdominal surgeries under GA.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Quality of recovery using QoR 15 score
研究概览
简要总结
This study is a prospective randomized controlled study comparing postoperative quality of recovery using QoR 15 questionnaire after administration of intravenous versus epidural opioids or non opioids in patients undergoing oncological abdominal surgeries under general anaesthesia. There are fours groups i.e. Group A will receive intravenous fentanyl 1-2 mcg as premedication, Group B will receive intravenous paracetamol 1 gm, Group C will receive Inj Bupivacaine 0.25% 8ml via epidural catheter, Group D will receive Inj Bupivacaine 0.25% with fentanyl 0.3mcg/kg via epidural catheter. General anaesthesia will be given as per standard technique. Repeat analgesia will be given as per duration of action of respective mode of analgesia given.The patients will then be transferred to the post anaesthesia care unit and monitored for pain at regular time intervals using an 11 point Numerical Rating Scale(NRS). If NRS> 4, then rescue analgesia will be given as per the group assigned. The patients will be followed up every 24 hours for 1 week to assess the quality of recovery using QoR 15 score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Known gastrointestinal or genitourinary cancer patients ASA grade III-IV Patients undergoing oncological abdominal surgeries under general anaesthesia.
排除标准
- •Patient refusal 2) BMI ≥ 30 kg/m 2 3) Clinically significant neurologic, psychiatric, CVS 4) Critically ill patient renal, respiratory and hepatic disease 5) Coagulation abnormalities 6) Local infection (for epidural) 7) Allergy to study drugs, pregnancy, drug abuse/ 8) Those who received analgesic, anxiolytic, antipschyciatric substance abuse medication within 6 hours before surgery 9) Redo surgery 10)Failure of extubation within 6 hours of surgery.
结局指标
主要结局
Postoperative Quality of recovery using QoR 15 score
时间窗: 1 week
次要结局
- Immediate Aldrete score(Return of bowel function in terms of peristalsis)
研究者
Arpita Thombre
Pt JNM Medical College