Comparison of the Efficacy of Celiac Plexus Blockade, Erector Spinae Compartment Blockade (ESP), and Intravenous Lidocaine Infusion Under Opioid-free Anesthesia in Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Life quality
研究概览
简要总结
Modern anesthesiology, in search of alternatives to opioid-based pain management, is turning to low-opioid and non-opioid protocols. Replacing opioids with non-opioid analgesics, co-analgesics, and regional and local anesthesia techniques allows avoiding the adverse effects of opioids while maintaining satisfactory analgesia. This is of particular importance in bariatric surgery, where reducing the incidence of respiratory depression, sedation, opioid hyperalgesia, and postoperative nausea and vomiting is a priority. Standard non-opioid anesthesia (OFA) includes ketamine, lidocaine, and dexmedetomidine infusions, while regional techniques additionally reduce the need for analgesics. Despite the widespread use of these methods, there is no clear data on the superiority of any of them in bariatric procedures.
详细描述
This is a prospective, randomized study with random assignment of patients to three groups:
ESP group: Before the procedure, a block of the erector spinae (ESP) compartment will be performed with approximately 20 ml of 0.25% ropivacaine at the Th4 level. The patient will be informed about the possibility of short-term discomfort if the block is performed before full induction of anesthesia.
Celiac plexus group: During general anesthesia, a celiac plexus block will be performed intraoperatively (20 ml of 0.5% ropivacaine). The patient will not feel discomfort due to general anesthesia.
Lidocaine IV group: Instead of a regional block, an intravenous infusion of lidocaine will be used.
All three methods are recognized methods of perioperative anesthesia. There is no placebo group in the study - intravenous infusion of lidocaine is the reference method, and both regional blocks are compared in relation to it and to each other.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years who underwent laparoscopic bariatric surgery
- •Must be able to sign agreement for study
排除标准
- •Patients with a history of allergic reactions to drugs
- •Patients with a history of drug addiction
- •Patients with chronic pain who require analgesics
- •History of hospitalization for psychiatric disorders
- •Preoperative pulse oximetry (SpO2) < 95 %
- •bradycardia (HR<50bpm)
- •hypotension
- •atrioventricular block
- •intraventricular or sinus block
- •Blood clotting disorders
- •Pregnant/lactating women
- •Cognitive impairment
- •Unable to read consent
研究组 & 干预措施
Erector Spinal BLock
Before the procedure, a block of the erector spinae (ESP) compartment will be performed with approximately 20 ml of 0.25% ropivacaine at the Th4 level. The patient will be informed about the possibility of short-term discomfort if the block is performed before full induction of anesthesia.
干预措施: ESP block (Drug)
Lidocaine IV
Instead of a regional block, an intravenous infusion of lidocaine will be used.
干预措施: Lidacaine (Drug)
Celiac Plexus Block
During general anesthesia, a celiac plexus block will be performed intraoperatively (20 ml of 0.5% ropivacaine). The patient will not feel discomfort due to general anesthesia.
干预措施: Celiac Plexus Block (Drug)
结局指标
主要结局
Life quality
时间窗: 1 day
Every patient will do OR-15
次要结局
- posoperative pain(1 day)
研究者
Tomasz Skladzien
MD PhD
Jagiellonian University