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临床试验/NCT07061262
NCT07061262已完成不适用

The Comparison of Postoperative Analgesic Efficacy Between External Oblique Plane Block and Subcostal Tap Block in Patients Undergoing Laparoscopic Cholecystectomy

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

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 Intervention

No peripheral nerve block

External Oblique Plane Block

Experimental

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

Active Comparator

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)

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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