Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine & IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8 mg nalbuphine compared with (IT) 0.4 mg nalbuphine.
详细描述
So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg with the addition of epidural dexamethasone could augment the postoperative analgesia and reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably more effective than lower doses to control moderate to severe post-operative pain. Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated blood glucose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical class I or II.
- •Undergoing laparotomy
- •Undergoing oophorectomy
- •Undergoing hysterectomy
- •Undergoing rectal mass excision
排除标准
- •Patient refusal.
- •Hypersensitivity to amide local anesthetics.
- •General contraindications to spinal anesthesia.
- •Cardiac diseases.
- •Hepatic failure.
- •Renal failure.
- •Respiratory failure.
- •Communication barriers.
研究组 & 干预措施
Placebo-nalbuphine
Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
干预措施: Placebo-nalbuphine (Drug)
Dexamethasone-nalbuphine
Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
干预措施: Dexamethasone-nalbuphine (Drug)
结局指标
主要结局
Pain score
时间窗: For 24 hours after surgery
Pain visual analog score (0: no pain, 100: worst imaginable pain)
次要结局
- Nausea and vomiting(For 24 hours after surgery)
- Sensory recovery(For 5 hours after induction of anaesthesia)
- Motor recovery(For 5 hours after induction of anaesthesia)
- First analgesic request(For 12 hours after induction of anaesthesia)
- Intraoperative heart rate changes(For 3 hours after induction of anaesthesia)
- Intraoperative mean arterial blood pressure changes(For 3 hours after induction of anaesthesia)
- Postoperative heart rate changes(For 24 hours after surgery)
- Postoperative mean arterial blood pressure changes(For 24 hours after surgery)
- Cumulative use of antiemetic(for 24 hrs after surgery)
- Cumulative use of rescue intravenous ketorolac(for 24 hrs after surgery)
- Cumulative use of rescue intravenous nalbuphine(For 24 hours after surgery)