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临床试验/NCT05725083
NCT05725083尚未招募不适用

Lower Thoracic Epidural Versus Erector Spinae Block for Postoperative Analgesia for Percutaneous Nephrolithotomy

Assiut University0 个研究点目标入组 42 人开始时间: 2024年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Total opioid consumption

研究概览

简要总结

compare the efficacy of Lower Thoracic Epidural with Erector spinae plane block (ESPB) for post-operative analgesia after Percutaneous Nephrolithotomy with a hypothesis that both Lower Thoracic Epidural and Erector spinae plane block are effective in providing post-operative analgesia.

详细描述

Percutaneous nephrolithotomy (PCNL) is the treatment of choice for patients with multiple or complex kidney or upper urinary tract stones, which necessitates the meticulous multi-modality analgesia due to mild to moderate pain originated from renal capsule dilation or nephrostomy-tube-related stress during the first 24 h after operation.

The main sources of the acute pain after PCNL are visceral pain originating from the kidneys and ureters, and somatic pain from the site incision. Renal pain is conducted through T10-L1 spinal nerves while ureter pain is conducted through T10-L2. Moreover, cutaneous innervation of the site of the incision is predominantly supplied by T10-T11 (T8-T12) because the incision site and tract for PCNL is usually used in the tenth to eleventh intercostal space, or in the subcostal area Blockade of both somatic and visceral nerves that innervate skin, muscle, kidneys, and ureters is required for the achievement of adequate analgesia after PCNL. Complete blockade of unilateral spinal nerves from T10 to L2 can provide sufficient analgesia during PCNL. This can be achieved by several regional techniques such as Lower Thoracic Epidural , Thoracic paravertebral block, Transversus abdominis block, Erector spinae block, and peri-tubal local anaesthetic infiltration .

PCNL surgery also has an increased risk for postoperative pulmonary complications because the procedure is performed near the diaphragm, especially, when approached through the upper pole of the kidney which increases the possibility of pleural and lung injuries. with poor control of the postoperative pain, this can result in decreased inspiratory and vital capacities and increase the incidence of lung atelectasis and postoperative hypoxemia. Multimodal analgesia techniques are utilized broadly to manage postoperative pain. The concept of multimodal analgesia implies not only providing analgesic drugs, but also performing nerve blocks with local anaesthetics.

Since Forrero et al. first described the Erector Spinae Plane Block (ESPB), the indications and clinical use of the block for different surgical interventions have been growing . Although, ESPB is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may derive from spread to the paravertebral and epidural space. Regional anesthesia may reduce the rate of chronic pain after surgery . Thoracic epidural blockade (TEB) using local anesthetic agents has been widely regarded as the gold standard for analgesia and reduction of associated complications following surgery.

Epidural analgesia was first accomplished by blockage with local anesthetics, and bupivacaine has been called the local anesthetic of choice for epidural infusion.. Epidural local anesthetics have been administered by continuous infusion in an attempt to minimize side effects , Nevertheless, hypotension as well as motor block , numbness , nausea and urinary retention have occurred.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Care Provider)

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

  • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
  • patients with the American Society of Anesthesiologists (ASA) physical status I/II,
  • Patients scheduled for elective Percutaneous Nephrolithotomy.

排除标准

  • Contraindication to local anesthesia :
  • Allergy to local anaesthetics , Infection at the site of injection , Coagulopathy
  • Chronic pain syndromes
  • Prolonged opioid medication
  • Patients who received any analgesic 24 h before surgery.

结局指标

主要结局

Total opioid consumption

时间窗: 48 hours postoperatively

Total opioid used

次要结局

  • First analgesic request(48 hours postoperatively)
  • Analgesic drug consumption other than Nalbuphine(48 hours postoperatively)
  • Block related complication(48 hours postoperatively)
  • Ambulation Time(48 hours postoperatively)
  • Incidence of postoperative nausea and vomiting(48 hours)
  • Heart rate in beats per minute(Intraoperatively)
  • Mean arterial pressure in mmHg(Intraoperatively)
  • Pain scores(48 hours postoperatively)
  • Patient satisfaction with anathesia(48 hours postoperativelyi)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keroles Heshmat Ghaly Seif

Resident

Assiut University

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