Comparing the Analgesic Properties of Intrathecal Pethidine Plus Dexamethasone Versus Intrathecal Bupivacaine Alone for Distal Lower Extremity Orthopedic Surgeries: A Randomized Comparative Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The Time of the first need for Rescue Analgesia
研究概览
简要总结
Bupivacaine is commonly used as a sole agent for spinal anesthesia unlike pethidine. Pethidine (meperidine) is a unique opioid. In addition to its analgesic activity, it also has significant local anesthetic activity. This property enables it to be used as the sole agent for spinal anesthesia
详细描述
pethidine compared favorably with bupivacaine as the sole anesthetic agent, providing excellent conditions for lower abdominal and pelvic surgery. Some studies showed that intrathecal pethidine has short motor recovery and prolonged postoperative analgesia in comparison to intrathecal bupivacaine. The side effects of pethidine in spinal anesthesia are pruritus nausea, vomiting and respiratory depression. A dose of 1mg/kg intrathecal pethidine provides surgical anesthesia .However, its effects are not widely available in recent studies.
Dexamethasone is used as an adjuvant to local anesthetic during spinal anesthesia and other techniques of regional anesthesia, it reduces pain and prolongs the duration of post-operative analgesia. It was shown that intrathecal dexamethasone reduces the complications of spinal anesthesia such as arterial hypotension, nausea, vomiting and shivering. The investigators suppose that addition of intrathecal dexamethasone to pethidine may be a better alternative to intrathecal bupivacaine during spinal anesthesia for lower extremity orthopedic surgery with better outcome and less side effects
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient acceptance.
- •Patients scheduled for lower extremity orthopedic surgery
- •Patient's age >18 years.
- •Patients with American Society of Anaesthesia (ASA)physical status I, II.
排除标准
- •Patient's age ≤18 years.
- •Uncooperative patients and patients with psychological problems.
- •Patients with contraindications to spinal anesthesia.
- •Patients with contraindications to bupivacaine or dexamethasone or pethidine.
- •Patients with ASA physical status III and IV.
- •Morbid obesity (BMI >35).
研究组 & 干预措施
Bupivacaine group
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 3 ml hyperbaric bupivacaine 0.5% alone.
干预措施: Bupivacaine Hydrochloride (Drug)
pethidine plus dexamethasone group
Patients will be anesthetized by spinal anesthesia by intrathecal injection of 1mg/kg preservative-free pethidine plus 4mg dexamethasone diluted to a volume of 3 ml with 0.9% sodium chloride
干预措施: Pethidine plus Dexamethasone (Drug)
结局指标
主要结局
The Time of the first need for Rescue Analgesia
时间窗: 24 hours postoperative
the time from the end of the intrathecal injection of the study drugs to the first report of pain that reached NRS 4 as described by the patient.
次要结局
- Intraoperative changes in the blood pressure measurements (The incidence of hypotension )(duration of the procedure)
- Intraoperative changes in the heart rate measurements (The incidence of bradycardia)(duration of the procedure)
- The onset of the sensory block(duration of the procedure)
- The onset of the motor block(duration of the procedure)
- The incidence of perioperative adverse events(duration of the procedure and 24 hours postoperative)
- The time of regression of sensory block to the 5th lumbar dermatome(Up to 12 hours postoperative)
- The time of regression of motor block to full motor function "Bromage score 0".(Up to 12 hours postoperative)
研究者
Salwa Samir El Sherbeny
Lecturer of Anesthesia, Intensive Care and pain management, Faculty of Medicine, Zagazig University
Zagazig University