Effect of Dexamethasone-Enhanced TAP Block Mixture on Postoperative Analgesia in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to first analgesic requirement (in hours)
研究概览
简要总结
The transversus abdominis plane (TAP) block is widely used as part of analgesia for abdominal surgeries such as laparoscopic cholecystectomy. While bupivacaine is commonly used for TAP blocks with reported success. Dexamethasone is often used as an adjuvant in prolonging duration of blocks; however, data on its efficacy in enhancing TAP blocks in laparoscopic cholecystectomy remain limited. This study aims to assess whether adding dexamethasone to bupivacaine in a TAP block improves postoperative pain control and reduces opioid consumption
详细描述
Hypothesis Patients receiving a dexamethasone-enhanced TAP block will have a longer duration of analgesia, lower postoperative pain scores, and reduced opioid requirements compared to patients receiving local anesthetic alone.
Objectives
- Primary Objective:
- To evaluate the time to first postoperative analgesic request.
- Secondary Objectives:
- To assess postoperative pain using the Visual Analog Scale (VAS).
- To evaluate the incidence of postoperative nausea and vomiting (PONV).
- To compare total postoperative analgesic consumption.
- To assess the need for rescue analgesia.
Methods Study Design
- Prospective, randomized, double-blind clinical trial. Study Population
- Adult patients (age ≥18), ASA physical status I to III, planned for elective laparoscopic cholecystectomy. Interventions
- All patients will undergo standard general anesthesia.
- TAP block will be performed pre-induction bilaterally by an experienced anesthesiologist blinded to the injectate.
- Patients will be randomized into two groups:
- Group A (Control): 20 ml solution containing 0.25% bupivacaine + normal saline
- Group B (Intervention): 20 ml solution containing 0.25% bupivacaine + 4 mg dexamethasone + normal saline
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult Patients
- •Laparoscopic Cholecystectomy Patients
- •Patients able to consent
排除标准
- •Patients allergic to dexamethasone
- •Allergic to Marcaine
- •Hemodynamically unstable
研究组 & 干预措施
Marcaine
干预措施: Marcaine- 0.25% (Drug)
Marcaine and Dexamethasone
干预措施: Dexamethasone enhanced TAP Block (Drug)
结局指标
主要结局
Time to first analgesic requirement (in hours)
时间窗: within 24 hours
次要结局
未报告次要终点
研究者
Mohamad-Ali Barada
Anesthesia Attending
Makassed General Hospital