Ultrasound Guided Lumbar Erector Spinae Block Using Bupivacaine - Magnesium Sulphate Versus Bupivacaine - Dexamethasone in Total Hip Replacement Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Post-operative analgesia duration
研究概览
简要总结
The current study was done to evaluate the effect of adding dexamethasone and magnesium sulfate to bupivacaine as adjuvants in an ultrasound-guided erector spinae block for patients undergoing total hip arthroplasty (THA), and to assess their impact on the timing of the first request for analgesia and on overall postoperative analgesic requirements.
详细描述
This study aimed to appraise the addition of dexamethasone and magnesium sulfate to bupivacaine as adjuvants by ultrasound-guided ESP block in patients having undergone total hip arthroplasty (THA) and its effect on the first analgesic request, total analgesic requirements.
This study was a prospective clinical study carried out to improve pain control after total hip arthroplasty (THA), which is a major orthopedic surgery often associated with significant postoperative discomfort. It is done to determine whether adding two commonly available medications-dexamethasone and magnesium sulfate-to the standard local anesthetic drug bupivacaine could enhance the effectiveness of the erector spinae plane (ESP) block.
The study included adult patients scheduled for elective total hip replacement surgery. All participants were carefully evaluated before enrollment to ensure they met specific inclusion criteria, such as appropriate age range, general health status, and absence of contraindications to regional anesthesia. Patients with conditions like known allergy to study drugs, severe coagulation problems, local infection at the injection site, or major systemic illness were excluded in order to maintain safety and reliability.
Participants were randomly divided into three groups. Each group received an ESP block under ultrasound guidance at the lumbar level at the end of surgery. Ultrasound was used to accurately identify the muscles, bones, and nerves of the lower back so that the anesthetic solution could be injected in the correct tissue plane. The groups are:
One group received bupivacaine plus saline (control group). A second group received bupivacaine with dexamethasone. A third group received bupivacaine with magnesium sulfate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status: ASA 1 or
- •Age > 21
- •Height 160 to 190 cm.
- •Body Mass Index (BMI) < 40.
排除标准
- •Refusing to participate in the study.
- •Coagulopathy.
- •Patients with history of drug allergies to study drugs.
- •Inability to cooperate.
- •Local disease as inflammation or infections at the site of puncture.
- •Uncontrolled diabetes, significant cardiopulmonary disease, and mental illness.
研究组 & 干预措施
Group BS (Bupivacaine-Saline): control
Group BS: The group will receive 30 ml 0.25% bupivacaine plus 5 ml normal saline.
干预措施: Bupivacaine-Saline (Combination Product)
Group BM (Bupivacaine-Magnesium)
the group will receive 30 mL 0.25% bupivacaine plus 5ml of 10% MgSO4
干预措施: Bupivacaine-Magnesium Sulphate (Combination Product)
Group BD (Bupivacaine-Dexamethasone)
The group will receive 30 mL 0.25% bupivacaine plus 5 ml normal saline containing 8 mg dexamethasone.
干预措施: Bupivacaine-Dexamethasone (Combination Product)
结局指标
主要结局
Post-operative analgesia duration
时间窗: 24-HOURS
Post-operative analgesia duration, which is measured as the time to the first analgesic request by the patient
次要结局
- Total postoperative opioid consumption(12 HOURS)
- Pain Intensity using Visual Analogue Pain Scale (VAS)(24-HOURS)
- Hemodynamic stability(24-HOURS)
- Postoperative complications(24-HOURS)