跳至主要内容
临床试验/NCT07542028
NCT07542028招募中不适用

Comparison of the Analgesic Effects of Transversalis Fascia Plane Block in Renal Transplantation Surgery

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月27日最近更新:
适应症
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
50
试验地点
1
主要终点
Pain Scores

研究概览

简要总结

Renal transplantation is a major surgical procedure associated with significant postoperative pain, particularly due to lower abdominal incision, deep tissue dissection, and extensive surgical manipulation. Effective postoperative pain control is therefore of great importance in this patient population, as inadequate analgesia may impair early mobilization, delay recovery, increase opioid consumption, and contribute to opioid-related adverse effects. In addition, optimal analgesic management may improve patient comfort and support enhanced postoperative outcomes.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare the analgesic effectiveness of transversalis fascia plane block in the postoperative period in patients who underwent renal transplantation.

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
  • American Society of Anesthesiologists (ASA) score III
  • Body Mass Index (BMI) between 18-30 kg/m2

排除标准

  • Patients under 18 and over 65 years of age
  • Patients with an ASA score other than III
  • Patients with a history of bleeding diathesis
  • BMI below 18 or above 30 kg/m2

研究组 & 干预措施

Transversalis Fascia Plane Block Group

Active Comparator

After the linear ultrasound (US) probe will be placed transversely above the iliac crest on the side of surgery, the abdominal wall muscle layers will be identified and the probe will be moved posteriorly until the transversus abdominis muscle and the transversalis fascia are visualized. A block needle will then be advanced using an in-plane technique, and after negative aspiration, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the fascial plane between the transversus abdominis muscle and the transversalis fascia. Proper spread of the local anesthetic in this plane will be confirmed by ultrasound imaging.

This procedure will be performed unilaterally on the surgical side. The standard intraoperative analgesic regimen will consist of intravenous tramadol (1 mg/kg) administered both before the incision and at the end of the procedure, with intravenous paracetamol (10 mg/kg) given exclusively at the end of the surgery.

干预措施: Transversalis Fascia Plane Block Group (Procedure)

Control Group

Active Comparator

Participants in the control group will not receive any regional block intervention.

The standard intraoperative analgesic regimen will consist of intravenous tramadol (1 mg/kg) administered both before the incision and at the end of the procedure, with intravenous paracetamol (10 mg/kg) given exclusively at the end of the surgery.

干预措施: Control Group (Procedure)

结局指标

主要结局

Pain Scores

时间窗: On the operation day

Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 12th, and 24th hours after surgery

次要结局

  • Intraoperative opioid consumption(Intraoperative period)
  • Postoperative Opioid Consumption(On the operation day)

研究者

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

Atakan Sezgi

Principal Investigator

Ankara Etlik City Hospital

研究点 (1)

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