Effect of Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
We aim to study the effect of adding magnesium sulfate as an adjuvant to the local anesthetic used in the combined Pectoralis Nerve Block II (PECS II) and stellate ganglion block for postoperative pain control in patients undergoing modified radical mastectomy.
详细描述
Post-operative pain from breast surgery can be controlled by regular pain medications such as paracetamol, non-steroidal anti-inflammatory (NSAIDs), and narcotics. Nerve blocks are commonly used as multimodal approaches for acute post-operative pain relief.
Pectoral and stellate ganglion blocks are regional anesthesia techniques that target the thoracic nerves and sympathetic nerve ganglia to provide analgesia for the upper extremity and chest regions. When combined, these blocks have shown promising results in alleviating perioperative pain for patients undergoing modified radical mastectomy.
Magnesium sulfate, a well-known adjuvant, has been studied extensively for its analgesic properties and anti-inflammatory 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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Female gender.
- •American Society of Anesthesiologists (ASA) physical status II or III.
- •Patients scheduled for elective modified radical mastectomy for breast cancer.
- •Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
排除标准
- •Bleeding tendency due to coagulopathy,
- •Patients with opioid dependence or alcohol or drug abuse,
- •Significant liver and renal sufficiency
- •Patients with psychiatric illnesses that prevent them from proper perception and assessment of pain.
- •Local infection at the site of the block.
- •Known hypersensitivity or allergy to magnesium sulfate or local anesthetics.
- •Patients with chronic pain syndromes or pre-existing neuropathic pain conditions.
- •Pregnant or lactating individuals.
研究组 & 干预措施
Group B
Patients will receive the combined (20 mL) pectoralis nerve block II (PECS II) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) mixed with 2.5 mL magnesium sulfate (10%), i.e., 250 mg.
干预措施: Bupivacaine + Magnesium sulfate (Drug)
Group A
Patients will receive the combined pectoralis nerve block II (PECS II)(20 mL) and stellate ganglion block (5 mL) using 0.5% bupivacaine (local anesthetic) without magnesium sulfate.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: 24 hours postoperatively
With numeric rating scale (NRS) rest score ≥ 3 or NRS evoked score ≥ 4, morphine will be administered intravenously by a dose of 0.05 mg/kg at 30-minute intervals until NRS rest score \< 3 or NRS evoked score \< 4.
次要结局
- Incidence of adverse events(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
- Time to first request analgesia(24 hours postoperatively)
研究者
Mahmoud Ahmed Ali Ali
Specialist of Anesthesia, Intensive Care Unit and Pain Relief
Cairo University