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临床试验/NCT06202040
NCT06202040已完成不适用

The Effect of Bilateral Rectus Sheath and Oblique Subcostal Transversus Abdominis Plane Block on Mechanical Power in Patients Undergoing Laparoscopic Cholecystectomy Surgery

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年12月22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
66
试验地点
1
主要终点
mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule.

研究概览

简要总结

The respiratory system receives mechanical power (MP) throughout time during mechanical ventilation. Despite its life-saving benefits, mechanical ventilation can cause ventilator-induced lung injury (VILI). Recently, VILI has been linked to mechanical power, or the amount of energy the mechanical ventilator sends to the respiratory system in a given time. The hunt for lung damage-reducing characteristics, notably after VILI and ARDS (Acute respiratory distress syndrome), has increased after Covid-19. Mechanical power must be used more to promote lung protection. We examined the effects of bilateral rectus sheath and OSTAP (Oblique Subcostal Transversus Abdominis Plane ) block on mechanically powered patients.

详细描述

MP is the energy transmitted over time to the respiratory system during mechanical ventilation. Although mechanical ventilation is a life-supporting treatment, it has the potential to cause damage to the lung structure in a process referred to as VILI. Recently, the degree of VILI has been associated with the amount of energy transmitted to the respiratory system by the mechanical ventilator within a specific time frame, which is referred to as mechanical power. After the occurrence of Covid-19, the search for parameters to reduce lung damage, especially following VILI and ARDS, has become more prominent. In this regard, promoting lung protection requires the more widespread use of mechanical power. We aimed to investigate the effect of bilateral rectus sheath and OSTAP block applied to patients on mechanical power.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Care Provider, Investigator, 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

  • •Patients aged between 18 and 65 years
  • •ASA 1-2 patients
  • •Patients undergoing elective laparoscopic cholecystectomy

排除标准

  • •Mental retardation,
  • •Severe presence of COPD,
  • •Uncontrolled Bronchial Asthma,
  • •Decompensated Heart Failure (NYHA 3-4),
  • •History of previous lung surgery,
  • •Patients unwilling to participate in the study,
  • •Local anesthetic allergy,
  • •History of chronic pain and treatment,
  • •Morbid obesity (body mass index (BMI) >35),
  • •Pregnancy,
  • •Patients converted to open cholecystectomy

研究组 & 干预措施

Group 1:OSTAPand RSB

Active Comparator

Group 1 will consist of patients who received general anesthesia, and just before the surgery started, bilateral OSTAP and RSB will be performed.

干预措施: Bilateral Rectus Sheath Block (RSB) will be performed. (Procedure)

Group 1:OSTAPand RSB

Active Comparator

Group 1 will consist of patients who received general anesthesia, and just before the surgery started, bilateral OSTAP and RSB will be performed.

干预措施: Bilateral Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) will be performed. (Procedure)

Group 2: Intravenous analgesia

No Intervention

Group 2 will include patients who received general anesthesia and were administered intravenous analgesia approximately 30 minutes before the end of the operation.

结局指标

主要结局

mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3) as a joule.

时间窗: Comen after intubation (before the block procedure), end of the surgery pre sugammadex administration and end of the surgery post sugammadex administration

Primary outcome measures will be based on intraoperative measurements taken from the mechanical ventilator, and mechanical power will be calculated from these measurements (mec power 1, mec power 2, mec power 3).

次要结局

  • the Quality of Recovery-15 Test (QoR-15T) [ Excellent (QoR-15 > 135 point), Good (122 ≤ QoR-15 ≤ 135 points), Moderate (90 ≤ QoR-15 ≤ 121 point), Poor (QoR-15 < 90 points) ](Postoperative assessments at 24 hours)
  • Number of rescue analgesic needs(Postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours)
  • Visual Analog Scale (VAS) for pain evaluation (0-10, 0 = no pain, 10 = the most severe pain).(postoperative assessments at 30 minutes, 2 hours, 8 hours, and 24 hours)

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esma Karaarslan

Medical Doctor

Konya City Hospital

研究点 (1)

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