Effect of Adding Magnesium Sulphate to Bupivacaine on the Quality of Ultrasound-guided Serratus Plane Block in Patients Undergoing a Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The duration of analgesia measured by the time of first analgesic request
研究概览
简要总结
To decrease post-operative pain in patients undergoing modified radical mastectomy.
详细描述
The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal analgesic regimens for a variety of thoracic procedures. It is designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural analgesia and may be associated with fewer side effects. It's straight forward to perform, with high success rate and minimal incidence of complications.
It was reported prolonged numbness over the area supplied by the lateral cutaneous branches of the T2-T9 spinal nerves using only 0.4 ml.kg-10.125% levobupivacaine. This is remarkable, because alternative techniques such as intercostal, interpleural and thoracic paravertebral block require relatively high concentrations and volumes of local anesthetics to produce similarly prolonged, multi-dermatomal thoracic analgesia.The duration of Serratus plane block is limited to the effect of administered local anesthetics (LAs). However, recently adjuvants such as epinephrine, ketamine and clonidine are added to LA solution in concentrations advocated for other peripheral blocks to prolong the effect of block with promising results.
Evidence supporting the presence of N-methyl-D-aspartate (NMDA) receptors in skin and muscles have led to the use of magnesium sulphate (MgSO4) (NMDA antagonist) via different routes for brachial plexus block and via neuraxial route. Until date, no study has been done to evaluate the role of MgSO4 as an adjuvant in SAP block. Therefore, the investigators intended this study to evaluate the role of MgSO4 as an adjuvant to bupivacaine in ultrasound (USG)-guided SAP block for postoperative analgesia in patients scheduled for modified radical mastectomy.
While the key requirement for successful regional anesthetic blocks is ensuring optimal distribution of local anesthetic around nerve structures, ultrasound guidance enables the anesthetist to secure an accurate needle position and to monitor the distribution of the local anesthetic in real time.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult, female patients, ASA physical status I, II, and III aged older than 18 years scheduled for modified radical mastectomy surgery under general anesthesia.
排除标准
- •Any known allergies to the study drugs. Anatomical abnormalities or infections in the serratus region. Bleeding disorders e.g. thrombocytopenia, high INR, high PT in chronic liver or impaired kidney). Patients on chronic pain medications or regularly receiving analgesics. Pregnant or breast feeding patients. Body Mass Index (BMI) more than 35.
研究组 & 干预措施
control group
The investigator injected 28.5 mL of Bupivacaine 0.5% and 1.5 mL of normal saline, a total volume of 30 ml, it was confirmed visually by the ultrasound.
干预措施: Normal saline (Drug)
magnesium sulphate group
The investigator injected 28.5 mL of bupivacaine 0.5% and 1.5 ml MgSo4 (150 mg), a total volume of 30 ml, it was confirmed visually by the ultrasound.
干预措施: Magnesium Sulphate (Drug)
结局指标
主要结局
The duration of analgesia measured by the time of first analgesic request
时间窗: post operative 24 hours
magnesium group showed delayed first analgesic request
次要结局
未报告次要终点
研究者
Abdelrhman Alshawadfy
clinical professor
Suez Canal University