Magnesium Sulphate Versus Fentanyl: Effects on the Quality of Bier Block: Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- VAS score
研究概览
简要总结
Intravenous regional anesthesia is one of the well-known techniques of regional anesthesia for short surgical operations on the upper and lower limbs. It was first introduced back in 1908. Later on it was popularized even more for the same purpose by using two tourniquets to isolate an exsanguinated extremity then injection of local anesthesia. It was proved over time to be safe and effective with minimal side effects and complications.
Magnesium sulfate (MgSO4) has been used over the 20th century for prevention and treatment of pre-eclamptic and eclampsia seizures during pregnancy because of its superior safety profile over other drugs used for the same purpose. The specific mechanisms of action of magnesium sulfate still unclear but are probably multi-factorial. It may act as a vasodilator on peripheral as well as cerebral vasculature, to decrease peripheral vascular resistance and/or relieve vasoconstriction. Additionally, it may also protect the blood-brain barrier and limit cerebral edema formation, or it may also act as a central anticonvulsant.
Fentanyl; was first introduced back in 1990 for palliative use as fentanyl patch. Few years later, it became available in different forms of administration being highly lipophilic. Few years later it became the most widely used synthetic opioid in medicine. It is an opioid analgesic with a rapid onset and short duration of action. It is a potent μ-opioid receptor pure agonist. Fentanyl is 50 to 100 times more potent than morphine. Fentanyl has a relatively wide therapeutic index, which makes it a very safe surgical anesthetic drug when monitored carefully.
详细描述
Two Intravenous lines will be inserted one at a distal point on the arm to be blocked and other one in the other arm for fluids infusion. The block will be executed by injecting the target medicine in 10 ml increments in a blinded manner of total of 40 ml (study drugs diluted in normal saline 0.9% solution.
- Group (L): will receive lidocaine 3 mg/kg total of 40 ml (control group)
- Group (M): will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.
- Group (F): will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.
Equipment: Local anesthetic agent: lidocaine HCl (2%), Rubber tourniquet, IV catheters (20- or 24-gauge), 500-mL or 1-L bag of IV solution (crystalloid), Infusion set, Pneumatic tourniquet, ideally with a double cuff, One Esmarch bandage (about 150 cm in length, 10 cm in width), Syringes.
Preparation: The patient lies in the supine position with the vein selected for block placement is readily accessible. Baseline vital signs are assessed; blood pressure, oxygen saturation, and ECG monitoring. Intravenous access in the non-operated extremity is obtained. Small doses of benzodiazepine for anxiolysis or small aliquots of opioids in case of discomfort will be available if needed. For safety and securing success, pneumatic cuffs will always be checked for air leaks prior to each IVRA procedure. Clinical staff performing the technique should have ready access to intra-lipid in case it is needed.
Technique:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for short surgical procedures (30 - 60 minutes) distal to elbow
- •age 18-55 years old
- •ASA I - II
- •both genders
- •average weight BMI (25 - 35).
排除标准
- •seizure diseases
- •allergy to the used medicine
- •local infection
- •patients with sickle cell anemia, Raynaud's disease, scleroderma, myasthenia gravis, significant cardiac or hepatic diseases.
研究组 & 干预措施
Group (L)
Patients will receive lidocaine 3 mg/kg total of 40 ml (control group)
干预措施: Lidocaine (Drug)
Group M
Patients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.
干预措施: Magnesium Sulphate (Drug)
Group F
Patients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.
干预措施: Fentanyl (Drug)
结局指标
主要结局
VAS score
时间窗: 2 hours
Onset of tourniquet pain after deflating proximal tourniquet. VAS consists of a straight line with the endpoints defining extreme limits WHERE 0='no pain AND 10= severe pain.
次要结局
- Total Supplement Analgesia(24 hours)
- Complications(24 hours)
- 3-point scale for sensory function(6 hours)
- 3-point scale for motor function(6 hours)
研究者
RAGAA AHMED HERDAN
Associate Professor of Anesthesia and Intensive Care
Assiut University