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临床试验/NCT05826652
NCT05826652已完成不适用

The Effect of Unilateral Subcostal Transversus Abdominis Plane Block Applied as Single or Multiple Injections on Pain in Laparoscopic Cholecystectomy Operations

Istanbul Medeniyet University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年12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
2
主要终点
Remifentanil consumption

研究概览

简要总结

It was aimed to control pain with right-sided subcostal transversus abdominis plane block application, which is performed by applying different techniques in laparoscopic cholecystectomy operations in this study. Considering that applying technique is important in this block, the results of this study can guide practitioners in this field.

详细描述

A total of 90 patients, aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for laparoscopic cholecystectomy, will be enrolled in this study. Exclusion criteria encompasse a history of allergy to local anesthetics, chronic analgesic use, psychiatric disorders, renal or hepatic dysfunction, coagulopathy, a body mass index (BMI) > 40 kg/m², and pregnancy. Patients in Group S receive a subcostal TAP block with a single injection, patients in Group T receive a subcostal TAP block with multiple injections, and patients in Group C will not receive any form of block.

Standard monitoring protocols will be implemented upon arrival in the operating theatre and heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) will be recorded during operation. Anesthesia will be induced using propofol (2 mg/kg) and fentanyl (1 μg/kg) and muscle relaxation is achieved with rocuronium (0.5 mg/kg). and maintained using sevoflurane in a 50:50 air/oxygen mixture at a flow rate of 1 L/min. Intraoperative analgesia will be provided through a remifentanil infusion at a rate of 0-0.2 μg/kg/min.

Prior to the initiation of surgery, the subcostal TAP block will be administered in Groups S and T under sterile conditions using ultrasound guidance. A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the left sides of the patients in Group S. The patients in Group T will be given three distinct injections to their left sides: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.

Laparoscopic cholecystectomy will be performed using four trocar placements on the right side of the abdomen. Postoperative analgesia was managed with a patient-controlled analgesia (PCA) device containing tramadol.

Postoperative remifentanil concumption will be estimated at the end of the operation. Assessments will be conducted at 30th minute, 1st, 3rd, 6st and 24th hours postoperatively, with parameters including pain, nausea, and total PCA consumption. Pain intensity will be measured using the Visual Analogue Scale (VAS; 0 = no pain, 10 = worst imaginable pain). Postoperative nausea and vomiting (PONV) will be evaluated using a verbal descriptive scale (VDS) (0: No PONV, 1: Mild PONV, 2: Moderate PONV, 3: Severe PONV) [10]. Patient satisfaction will beevaluated at discharge using a five-point Likert scale (1 = strongly unsatisfied, 5 = strongly satisfied). Complications, including infection, bleeding, and subcutaneous emphysema will be documented.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-65 years old
  • •Patients scheduled for laparoscopic cholecystectomy operations

排除标准

  • •Those who have previously had neurological and psychiatric disease symptoms and use drugs (TIA, syncope, dementia, depression, bipolar disorder, etc.)
  • •Patients with known allergy to local anesthetics
  • •Chronic opioid or corticosteroid users
  • •Those with coagulopathy
  • •Those with local or systemic infections
  • •BMI>40 kg/m2

研究组 & 干预措施

Multiple injection subcostal transversus abdominis plane block

Active Comparator

. The patients in multiple injection will be given three distinct injections: 10 mL of 0.25% bupivacaine above the transversus abdominis muscle adjacent to the linea semilunaris, 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the midclavicular line and 5 mL of 0.25% bupivacaine between the transversus abdominis and internal oblique muscles in the subcostal region above the anterior axillary line.

干预措施: Multiple injection subcostal transversus abdominis plane block (Other)

Single injection subcostal transversus abdominis plane block

Active Comparator

A single injection of 20 mL of 0.25% bupivacaine will be administered above the transversus abdominis muscle adjacent to the linea semilunaris to the patients in Group S.

干预措施: Single injection subcostal transversus abdominis plane block (Other)

Without Block

Active Comparator

The patients in this group will not receive any block

干预措施: Without Block (Procedure)

结局指标

主要结局

Remifentanil consumption

时间窗: up to 2 hours

Intraoperative opiod consumption

Tramadol consumption

时间窗: 10 minutes, 30 minutes, 1, 3, 6, 24 hours postoperatively

Postoperative opiod consumption

次要结局

  • Visual analog scale(24. hour)
  • Postoperative nausea and vomiting(24. hour)
  • Patient satisfaction(24. hour)
  • Visual analog scale(30. minute)
  • Visual analog scale(1. hour)
  • Visual analog scale(3. hour)
  • Visual analog scale(6. hour)
  • Postoperative nausea and vomiting(30. minute)
  • Postoperative nausea and vomiting(1. hour)
  • Postoperative nausea and vomiting(3. hour)
  • Postoperative nausea and vomiting(6. hour)

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

mesure gul nihan ozden

Medical Doctor

Istanbul Medeniyet University

研究点 (2)

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