Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Time for first requirement of rescue analgesia
研究概览
简要总结
The aim of this study is to detect weather peritoneal block or erector spinae plane block will provide the most ideal analgesia for patients undergoing laparoscopic cholecystectomy. Peritoneal block by instillation of local anesthetic into the peritoneal cavity will act by blocking the free afferent nerve endings in the peritoneum and the systemic absorption of local anesthetic from the peritoneal cavity may also play a part in reduced pain.
On the other hand ,the erector spinae plane block is a novel analgesic technique that provide both visceral and somatic analgesia due to its communication with the paravertebral space. Local anesthetic mixture of lidocaine , magnesium sulphate and epinephrine will be used for both techniques.
详细描述
The pain that a patient feels after laparoscopic cholecystectomy results from three different and clinically separate components: somatic pain due to trocar insertion sites , visceral pain due to surgical dissection and tissue handling at the gall bladder bed, and shoulder pain due to retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm. Ineffective treatment of post laparoscopic cholecystectomy pain may delay recovery and mandate inpatient admission and therapy and increase the cost of such care.
The aim of this study is to evaluate the analgesic effect of Erector spinea plane block in comparison with peritoneal block for laparoscopic cholecystectomy. Serum level of cortisol as a stress biomarker ,perioperative primary hemodynamics ,visual analogue scale , patient request for rescue analgesia and occurrence of side effects are the parameters for comparison between both techniques. Each patient will be followed up for 24 hours postoperatively.
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
- Single (Participant)
盲法说明
- Single blind (participant) study
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
- •American physical status classes I and II
排除标准
- •Patient refusal.
- •Pregnancy
- •Neuromuscular diseases (as myopathies, myasthenia gravies...)
- •Hematological diseases.
- •Bleeding diseases.
- •Coagulation abnormality.
- •Psychiatric diseases.
- •Local skin infection at site of the block.
- •Local skin sepsis at site of the block.
- •Known intolerance to the study drugs.
- •Body Mass Index > 40 Kg/m
- •Chronic renal disease.
- •Chronic hepatic disease.
- •Preexisting neurological deficit.
- •Conversion to open cholecystectomy
- •Excessively long surgical times (> 90 min)
结局指标
主要结局
Time for first requirement of rescue analgesia
时间窗: for 24 hours after surgery
an analgesic (nalbuphine 10 mg ) will be administer postoperatively on patient request in case of the pain score ≥ 4/10 on VAS. It represent the end point of the study which determines the duration of analgesia
次要结局
- end tidal CO2(immediately after intubation and ever 10 min till the end of surgery.)
- serum cortisol level(preoperative and one hour postoperative.)
- nausea(immediately after recovery and every 4 hours for 24 hour postoperatively)
- heart rate(one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.)
- Intensity of Abdominal Pain: visual analogue scale(immediately after recovery ,then every 4 hours for 24 hour.)
- Intensity of Shoulder Pain: five point scale(immediately after recovery ,then every 4 hours for 24 hour.)
- Peripheral oxygen saturation(one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.)
- mean arterial blood pressure(one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.)
- circumoral numbness(immediately after recovery and every 4 hours for 24 hour postoperatively)
- tinitus(immediately after recovery and every 4 hours for 24 hour postoperatively)
- Post-operative total analgesic requirement(for 24 hours postoperatively.)
- vomiting(immediately after recovery and every 4 hours for 24 hour postoperatively)
- dizziness(immediately after recovery and every 4 hours for 24 hour postoperatively)