跳至主要内容
临床试验/NCT06862609
NCT06862609招募中不适用

Effect of the Quadro-Iliac Plane Block on Quality of Recovery Following Laparoscopic Inguinal Hernia Surgery: A Prospective, Randomized, Controlled, Double-Blind, Multicenter Study

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
The primary outcome is the QoR-15 score (0-150 point) at 24 hours postoperatively.

研究概览

简要总结

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge.

详细描述

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge. Recently, Tulgar and colleagues introduced a novel fascial plane block known as the "quadro-iliac plane block". Quadro-iliac plane block is performed within the quadro-iliac plane, located between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. In their study, Tulgar et al. bilaterally injected 40 mL of methylene blue into the quadro-iliac plane. They observed widespread dye dispersion along the anterior and posterior surfaces of the quadratus lumborum muscle, transversalis fascia, ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. Based on these findings, quadro-iliac plane block has been proposed as a potentially effective technique for managing acute or chronic pain in the lumbosacral, abdominal, and hip regions.

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 (Participant, 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

入选标准

  • Patients aged 18-65 years
  • Undergoing elective,
  • unilateral laparoscopic inguinal hernia repair
  • Receiving general anesthesia

排除标准

  • Patients who refuse to provide consent
  • Patients with contraindications to regional anesthesia
  • Patients with impaired consciousness
  • Patients with coagulopathy
  • Patients with infections at the block site
  • Emergency cases

研究组 & 干预措施

control group

Other

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1). Rescue analgesia (IV tramadol 1 mg/kg) will be administered if Numerical rating scale scores are ≥3. IV ondansetron (4 mg) will be given for nausea and vomiting.

干预措施: Quadro iliac plane block (Other)

Quadro iliac plane block

Active Comparator

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1). Rescue analgesia (IV tramadol 1 mg/kg) will be administered if Numerical rating scale scores are ≥3. IV ondansetron (4 mg) will be given for nausea and vomiting. Group Q patients will receive quadro iliac plane block in addition to standard analgesia.

干预措施: Control group (Other)

结局指标

主要结局

The primary outcome is the QoR-15 score (0-150 point) at 24 hours postoperatively.

时间窗: 24 hours

The primary outcome is the QoR-15 score (0-150 point) at 24 hours postoperatively.

次要结局

未报告次要终点

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

Muhammed Halit Satici

Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Konya City Hospital

研究点 (1)

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