Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- effect on postoperative pain after abdominal hysterectomy using visual analog score
研究概览
简要总结
The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.
详细描述
Abdominal Hysterectomy (AH) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control.
Postoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. Opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. Nonopioid drugs can decrease opioid usage and dependency.
Different adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain.
According to numerous reports, Magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries.
The analgesic properties of magnesium are based on acting as a non-competitive antagonist of N-Methyl-D-Aspartate (NMDA) receptors in central nervous system and regulating the calcium influx into the cell. These properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves In the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via G-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance P and glutamate) from primary afferent terminals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients between 40-65 years old
- •Patients with ASA clinical status I/II
- •Patients eligible for abdominal hysterectomy
- •Oncological surgery
排除标准
- •Body mass index (BMI) ≥ 40/kg / m2
- •Previous abdominal surgery (except cesarean section)
- •Severe cardiovascular, renal, and hepatic dysfunction
- •Contraindications to spinal anesthesia
- •Neuromuscular diseases
- •Inappropriate for spinal anesthesia
- •Patient refusal
研究组 & 干预措施
placebo
will include 30 patients who will receive
- intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline.
- 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia then 250 ml of isotonic saline infusion over 2 hours.
干预措施: Magnesium sulfate (Drug)
intrathecal
will include 30 patients who will receive
- Intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus magnesium sulfate 30 mg of 0.5 ml volume.
- 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia, then 250 ml of isotonic saline infusion over 2 hours.
干预措施: Magnesium sulfate (Drug)
intravenous
will include 30 patients who will receive
- 30 mg/kg magnesium sulfate at a concentration of 100 mg/ml (regarding the ideal body weight) in 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia (intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline), and then 10 mg/kg/h magnesium sulfate in 250 ml isotonic saline infusion over 2 hours.
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
effect on postoperative pain after abdominal hysterectomy using visual analog score
时间窗: Baseline
the pain intensity assessment at rest and on movement (from lying to sitting on the bed) using Visual analog score (VAS) This will measure pain intensity from 0 to 10 (goal is to be \< 4) 0: no pain 3: mild pain 7: moderate pain 10: severe pain
次要结局
- sedation by Ramsay sedation scale(Baseline)
- time of the first opioid request(Baseline)
- Mean arterial blood pressures (MAP)(Baseline)
- Heart rate (HR)(Baseline)
研究者
Marwa Salah Hassanein
principal investigator
Assiut University