Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Laparoscopic Cholecystectomy: A Randomized Controlled Trial on Opioid Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Tramadol consumption
研究概览
简要总结
The study is planned as a single-center prospective randomized study and includes patients undergoing laparoscopic cholecystectomy. The aim of this study is to compare postoperative analgesic efficacy of erector spinae plane block and thoracic paravertebral block. Primary outcome is 24-hour postoperative opioid consumption.
详细描述
All patients in the operating room receive the same anesthetic management under standard monitoring modalities. Both erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) are performed under ultrasound guidance at the T8 level using a linear probe and a longitudinal out-of-plane technique before induction of anesthesia. For ESPB, 10 mL of 0.375% bupivacaine is injected bilaterally between the deep fascia of the erector spinae muscle and the transverse process. For TPVB, 10 mL of 0.375% bupivacaine is injected bilaterally into the paravertebral space. After standard anesthesia induction, anesthesia is maintained with inhalation agents. Four milligrams of dexamethasone and 8 mg of ondansetron are administered for postoperative nausea and vomiting prophylaxis. As part of multimodal analgesia, all patients receive 1 g of paracetamol and 20 mg of tenoxicam.
All patients are followed according to a standardized postoperative analgesia protocol, which includes tramadol patient-controlled analgesia (10 mg bolus, 20-minute lockout). Postoperative static and dynamic pain scores are evaluated using the numeric rating scale (NRS) at 0, 1, 4, 6, 12, 18, and 24 hours. If the NRS score is greater than 3, 0.5 mg/kg meperidine is administered as rescue analgesia.
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 (Care Provider, 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
- •Elective cholecystectomy
- •Age >18years
- •American Society of Anesthesiologists classification I-III
排除标准
- •Presence of contraindications for using regional anesthesia ( not having patient approval, bleeding diathesis or use of anticoagulants, infection at the injection site, and allergy to local anesthetics)
- •Chronic analgesic use
- •Open cholecystectomy or conversion to open cholecystectomy
研究组 & 干预措施
Group 1: ESPB
Erector spinal plane block
干预措施: ESPB (Procedure)
Group 2: TPVB
Thoracic paravertebral block
干预措施: TPVB (Procedure)
Group 3: IV
intravenous analgesia
干预措施: IV (Procedure)
结局指标
主要结局
Tramadol consumption
时间窗: postoperative 24 hours
amount of postoperative 24-hour tramadol consumption
次要结局
- Amount of fentanyl(during surgery)
- Static and dynamic pain score(postoperative 24 hours)
- First rescue analgesic time(postoperative 24 hours)
- Number of patients required rescue analgesic.(postoperative 24 hours)
- Nausea and vomiting(postoperative 24 hours)
- Complications(postoperative 24 hours)
- Quality of recovery(postoperative 24 hours)
- Length of hospital stay(up to 1 week)
研究者
Ozlem Turhan
Attending Anesthesiologist
Istanbul University
