The Comparison of Postoperative Analgesic Efficacy Between External Oblique Plane Block and Subcostal Tap Block in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
The study aims to compare the efficacy of the external oblique plane block and the subcostal plane block in providing pain relief during perioperative anaesthetic management. As intraoperative haemodynamic stability is an important factor for surgeons to achieve better outcomes due to its effect on the quality of laparoscopic intervention, the investigator will observe its impact on this matter.
Ninety patients scheduled for elective surgery will be randomly assigned by a closed-envelope method into three groups (n = 30) receiving either a subcostal plan block, an external oblique plane block, or a control block preoperatively. Each group receive standardised general anaesthesia and perioperative pain management protocol. The data to be recorded include a numeric rating scale, intraoperative and postoperative analgesic use, intraoperative haemodynamic parameters, and VAS score. Moreover, block performance time, motor block and side effects or complications will be noted.
详细描述
All patients will receive standard general anaesthesia under standard monitorization; induction with 0,1-0,4 mg/kg midazolam, 2-2,5 mg/kg propofol, 1-2 mcq/kg fentanyl, 0,6-1,0 mg /kg rocuronium followed by 2% MAC sevoflurane in an air-oxygen mixture for maintenance of anaesthesia. Randomization is designed with concealed opaque envelope in a 1:1 ratio into two block groups (n= 30): subcostal plane block (Group A) and external oblique plane block (Group B) and control group ( Group C ). All blocks will be performed before surgical incision by a single experienced regional anaesthesiologist (A.A.) under ultrasound guidance with same local anaesthetic doses: 0.25% bupivacaine anaesthetic solution of 20 ml. The anaesthesia technician will record the duration of the block procedure. Then the investigator will apply dexamethasone 8 mg (IV), NSAIDs and after the patient will be ready for surgical incision. Intraoperative haemodynamic values (heart rate, systolic and mean arterial pressure) will be recorded by the same technician. The same analgesia protocol will be applied, consisting of an infusion of remifentanil (0.01 to 0.1 μg · kg-1 · min-1) if only needed to maintain heart rate and mean blood pressure within 20% of pre-induction values, and 1 g of paracetamol. Pain will be evaluated using both a numeric rating scale (0-10) and a verbal rating scale, starting at the post-anaesthesia care unit (PACU) and at time intervals of 2, 6, 12, and 24 hours postoperatively. Patients with persistent pain scores of higher than 4 out of 10 will receive rescue analgesia with 1mg/kg (maximum daily dose, 4x1) tramadol and 1 g (maximum daily dose, 4x1) paracetamol.
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
- Double (Participant, 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
- •American Society of Anaesthesiologists (ASA) Physical Status classification I to III
- •Patients who will give informed consent to peripheral nerve blocks
排除标准
- •Refusal to participate in the study
- •History of neurologic deficits or neuropathy
- •Infection at the site of the block application
- •Coagulopathy
- •bleeding disorders
- •Allergy to local anaesthetics
- •Uncooperative patients who cannot reliably respond to verbal pain evaluation
- •Kidney Failure
- •Liver Failure
研究组 & 干预措施
Control
No peripheral nerve block
External Oblique Plane Block
Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, an external oblique plane block will be performed by the same anaesthesiologist under ultrasound guidance, using an external oblique muscle approach, in addition to standard analgesia applied in the control group.
干预措施: External Oblique Intercostal Plane Block (Procedure)
Subcostal Plane Block
Right after general anaesthesia induction and patient intubation, the patient will be placed in a supine position. Following sterile skin preparation, a subcostal block will be performed by the same anaesthesiologist under ultrasound guidance with subcostal approach, in addition to standard analgesia applied in the control group.
干预措施: Subcostal TAP block and spinal anesthesia group (STAP) (Procedure)
结局指标
主要结局
Pain Score
时间窗: postoperative day 1
Numeric rating scale (NRS) worst pain imaginable as 10 points to zero for no pain.
次要结局
- The total amount of analgesic drugs used(postoperative day 1)
