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临床试验/NCT06653439
NCT06653439已完成不适用

Analgesic Effect of Ultrasound-Guided Bilateral Subcostal Anterior Quadratus Lumborum Block in Laparoscopic Colorectal Surgery: A Randomized Controlled Trial

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Cumulative opioid consumption in the first 24 hours after surgery

研究概览

简要总结

Effective postoperative pain management is crucial for promoting early recovery and ambulation following laparoscopic colorectal surgery. Regional anesthesia techniques, like interfascial plane blocks, are increasingly being used to achieve this. The quadratus lumborum block (QLB) is a relatively new approach in abdominal surgeries, providing significant pain relief by blocking both somatic and sympathetic nerves. In particular, the anterior QLB technique allows local anesthetic to spread to the thoracic paravertebral space, making it potentially more effective for postoperative analgesia. The hypothesis of this study is that bilateral subcostal anterior QLB can reduce both postoperative pain and opioid consumption in laparoscopic colorectal surgery.

详细描述

Postoperative pain management is a critical factor in enhancing recovery and ambulation following laparoscopic colorectal surgery. Effective analgesia is necessary to reduce complications, improve patient comfort, and shorten hospital stays. In this context, multimodal analgesia is a commonly used strategy that combines various analgesic drugs, such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids, to manage pain more effectively by targeting different pathways.

Although opioids are considered the gold standard for postoperative pain control, their use is associated with several undesirable side effects, including nausea, vomiting, dizziness, constipation, and respiratory depression. These opioid-related complications can delay recovery, increase patient discomfort, and extend hospital stays. Therefore, minimizing opioid consumption while still providing effective pain relief is a primary goal in postoperative pain management, particularly for surgeries such as laparoscopic colorectal procedures.

To achieve this goal, regional anesthesia techniques have gained increasing popularity. These techniques, such as interfascial plane blocks, have the potential to reduce opioid use and improve pain control by targeting specific nerve pathways. One of the more recent approaches is the quadratus lumborum block (QLB), which involves the injection of local anesthetics near the quadratus lumborum muscle. This block is particularly useful in abdominal surgeries because it can provide pain relief by affecting both somatic and sympathetic nerves, leading to broader and more effective pain coverage.

The QLB has four different approaches: anterior, lateral, posterior, and intramuscular. The anterior QLB is of particular interest in this setting because it involves the injection of local anesthetic between the quadratus lumborum and psoas muscles, potentially allowing the anesthetic to spread into the thoracic paravertebral space. This spread could result in the blockade of both the somatic nerves and the thoracic sympathetic chain, offering more comprehensive pain relief that is beneficial for abdominal surgeries like colorectal procedures.

The potential advantages of the anterior QLB in laparoscopic colorectal surgery include reduced postoperative pain, decreased opioid consumption, and fewer opioid-related side effects. Additionally, regional anesthesia techniques like QLB may reduce postoperative complications, including respiratory issues, which are particularly important in abdominal surgeries that involve the diaphragm and lower thoracic nerves.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Researchers, surgeons and nurses, and those involved in study outcome analysis will not be aware of the randomization of the group. Due to the nature of the intervention, patient blinding was not feasible. Block quality and standardization will be performed by an anesthetist experienced in regional anesthesia for S-QLB block.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group S-QLB

Active Comparator

A bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)

干预措施: Bilateral ultrasound guided Subcostal Quadratus Lumborum Block (Procedure)

Group S-QLB

Active Comparator

A bilateral S-QLB (20 ml, %0.25 bupivacaine, bilaterally) + IV morphine patient-controlled analgesia (PCA)

干预措施: IV morphine PCA (Drug)

Group Control

Active Comparator

IV morphine PCA

干预措施: Control (Procedure)

Group Control

Active Comparator

IV morphine PCA

干预措施: IV morphine PCA (Drug)

结局指标

主要结局

Cumulative opioid consumption in the first 24 hours after surgery

时间窗: Postoperative day 1

The primary outcome will be defined as cumulative opioid consumption during the first 24 hours following surgery, which will be calculated in intravenous morphine milligram equivalents (IV-MME), encompassing both PCA-administered morphine and rescue intravenous tramadol, according to the standardized ESAIC conversion guidelines. Patients can request opioids via a PCA device when their NRS score is≥ 4.

次要结局

  • Heart Rate(Postoperative day 1)
  • Cumulative opioid consumption in the first 12 hours after surgery(Postoperative 12 hours.)
  • Intraoperative Remifentanil Consumption(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 150 minutes.)
  • Numerical Rating Scale Assessment of Postoperative Pain(Postoperative day 1)
  • Time to First Opioid Demand via PCA(Postoperative day 1)
  • Extent of Sensory Block(From block administration to 30 minutes post-procedure.)
  • The number of patients who required rescue analgesia.(Postoperative day 1)
  • The patient number of Rescue antiemetic Requirement(Postoperative day 1)
  • The number of patients with complications(Postoperative 7 days on an average)
  • Mean Arterial Pressure(Postoperative day 1)
  • Time to First Mobilization(Postoperative day 3)
  • Time to First Flatus(Postoperative day 3)
  • Time to First Oral Intake(Postoperative day 3)
  • Length of Hospital Stay(Postoperative day 10)

研究者

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

Esra Turunc

Assistant professor

Ondokuz Mayıs University

研究点 (1)

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