Dexamethasone as a Bupivacaine Adjuvant in Ultrasound-guided Erector Spinae Plane Block for Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- The intensity of postoperative pain
研究概览
简要总结
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.
详细描述
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. The most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the C4 dermatome. Due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following LC.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex
排除标准
- •Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
- •Altered conscious level
- •Pregnancy
- •Body mass index (BMI > 35)
- •Advanced hepatic or renal failure
- •Chronic opioid consumption
研究组 & 干预措施
Erector Spinae Plane Block
Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.
干预措施: Erector Spinae Plane Block (Drug)
Dexamethasone/ Erector Spinae Plane Block
Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.
干预措施: Dexamethasone/ Erector Spinae Plane Block (Drug)
结局指标
主要结局
The intensity of postoperative pain
时间窗: 24 hours after surgery
Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)
次要结局
未报告次要终点
研究者
Seham Mohamed Moeen Ibrahim
Assistant professor of Anesthesia and Intensive Care
Assiut University