A Comparative Study Between the Effect of Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Duration of post-operative analgesia
研究概览
简要总结
The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia.
This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open abdominal surgeries in the early postoperative period regarding pain relief After approval of the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal surgeries were included in the study, and were divided into three groups (n=22; each); group M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of 10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20 ml bupivacaine plus 5 ml 0.9% NaCl.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II
- •aged 18 to 65 years
- •body weight ≥ 60 kg and ≤ 90 kg
- •scheduled for open abdominal surgeries
排除标准
- •Patients' refusal to participate in the study
- •history of allergy to the medications used in the study
- •hepatic disease
- •renal disease
- •known neurologic disorders
- •psychiatric disorder
- •chronic treatment with calcium channel blockers
- •hyper-magnesemia
- •coagulopathy
- •anatomical abnormalities
- •hemodynamic instability
- •local infection
- •suspected intra- abdominal sepsis
研究组 & 干预措施
Bupivacaine Magnesium sulphate group
Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
干预措施: Bupivacaine- Magnesium (Drug)
Bupivacaine Dexamethasone group
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.
干预措施: Bupivacaine dexamethasone (Drug)
bupivacaine saline group
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.
干预措施: Bupivacaine saline (Drug)
结局指标
主要结局
Duration of post-operative analgesia
时间窗: 24hours
Time from completion of the block to the first request of rescue analgesia.
次要结局
- Mean arterial blood pressure(24 hours)
- Heart rate(24 hours)
- The severity of post-operative pain at rest(24 hours)
- The severity of post-operative pain with movement (bilateral knee flexion)(24 hours)
- Number of patients requiring post-operative rescue analgesia(24 hours)
- Total dose of pethidine given(24 hours)
- Occurrence of nausea and/or vomiting:(24 hours)
- Time to first ambulation(24 hours)
- The analgesic satisfaction at 24 post-operative hours(24 hours)
- Inadvertent femoral nerve block(24 hours)
- Local Anesthetic Systemic Toxicity (LAST):(24 hours)
研究者
Ghada M.Samir
Assistant Professor
Ain Shams University