The Analgesic Efficacy of Adding Magnesium Sulfate Versus Ketorolac to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Block (A Prospective- Double-blinded Randomized Controlled Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the cumulative morphine consumption
研究概览
简要总结
Despite many regional anesthetic techniques have been described for anesthesia of the brachial plexus which is responsible for the sensory and motor innervation of entire upper limb, still, supraclavicular block (SCB) is the regional anesthetic technique of choice.
SCB has been described as the spinal anesthesia of the upper limb as it offers dense anesthesia of the brachial plexus for the surgical procedures below the arm from elbow to hand. Although the SCB has a high incidence of complications like pneumothorax, the use of ultrasound-guided block improved the safety for the patient. There are several adjuvants have been added to SCB aiming for prolongation of the duration of peripheral nerve block as fentanyl, alpha 2 adrenergic agonist (Dexmedetomidine, Clonidine), tramadol, ketorolac and Magnesium sulfate.
Magnesium has anti-nociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.
Non-Steroidal Anti-Inflammatory drugs (NSAID) inhibit synthesis of prostaglandins from arachnoid acid in phospholipid membranes resulting in decreased afferent nociceptive signals from the site of surgery. There are a lot of studies supported the analgesic effect when NSAIDs are concentrated at a peripheral site compared to the systemic administration therapy. Ketorolac is a parenteral NSAIDs. Studies have shown that ketorolac as an adjuvant to local anesthetics during peripheral nerve block enhanced duration and quality of analgesia.
详细描述
Eighty adult patients scheduled for upper limb surgeries from elbow to hand will be enrolled in the study after obtaining approval of the local institutional ethics committee and local institutional review board at Fayoum University Hospital. A detailed informed consent will be signed by the eligible participants before recruitment and randomization.
80 patients will be chosen to receive either Mg (group M, n=40) or ketorolac (group K, n=40) randomly by a computer-generated table. The randomization sequence will be concealed in opaque sealed envelopes. The envelopes will be opened by the study investigator just after recruitments and admission to the operation room. Only participants and care providers will be blinded to the group allocations. The consolidated standards of reporting trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed.
Patient preoperative preparations:
Preoperative investigations will be done according to the local protocol designed to evaluate the patients. It will include complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile, and ECG.
Before surgery, the participants will receive education about the (NRS) from (0-10 mm) (where 0=no pain and 10 = worst comprehensible pain) and the details of the nerve block procedures.
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
- 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 (ASA) physical status from I to III participants who were scheduled for surgical procedures of the arm from elbow to hand
排除标准
- •Patient refusal.
- •Contraindication to regional anesthesia (coagulopathy, allergy to the local anesthetic or any adjuvants added, severe thrombocytopenia, pre-existing neuropathy in the operative limb, infection at puncture site).
- •Pregnant or lactating women.
- •Hepatic or renal dysfunction.
- •Any drug or opioid abuse.
- •Surgical procedures for more than 3h.
- •Advanced cardiac diseases.
研究组 & 干预措施
the intervention group (M) magnesium sulfate
a 6ml of magnesium sulfate 10% (600mg) will be added to 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block
干预措施: Magnesium sulfate (Drug)
the intervention group (M) magnesium sulfate
a 6ml of magnesium sulfate 10% (600mg) will be added to 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block
干预措施: supraclavicular block (Procedure)
the intervention group (K) ketorolac
a 2ml of ketorolac (30mg) will be added to 4ml of normal saline and 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block
干预措施: Ketorolac Tromethamine (Drug)
the intervention group (K) ketorolac
a 2ml of ketorolac (30mg) will be added to 4ml of normal saline and 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block
干预措施: supraclavicular block (Procedure)
结局指标
主要结局
the cumulative morphine consumption
时间窗: At 24 hours postoperative
In milligrams
次要结局
- incidence of opioid related side-effects(5 minutes after supraclavicular block till discharge from PACU)
- incidence of adverse effects related to the block(5 minutes after supraclavicular block till discharge from PACU)
- Duration of surgical procedures(5 minutes after completion of surgical procedures)
- Assessment of heart rate(from the start of the block till completion of surgical procedures)
- Assessment of mean blood pressure(from the start of the block till completion of surgical procedures)
- time to the first requirement of analgesic supplement(5 minutes After supraclavicular block till first requirement of analgesic)
- numerical rating scale (NRS) of postoperative pain(at 24 hours postoperative)
- Assessment of Oxygen saturation(from the start of the block till completion of surgical procedures)
- Age(10 minutes before surgery)
- Height(10 minutes before surgery)
- Body mass index(10 minutes before surgery)
- Assessment of respiratory rate(from the start of the block till completion of surgical procedures)
- Weight(10 minutes before surgery)
研究者
Safaa Gaber Ragab
Lecturer of anesthesiology
Fayoum University Hospital