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临床试验/NCT06787898
NCT06787898已完成不适用

USG-Guided Retrolaminar Block Improves Postoperative Gastrointestinal System Functions in Percutaneous Nephrolithotomy Patients: A Prospective, Randomised, Clinical Study

Elazıg Fethi Sekin Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1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
60
试验地点
1
主要终点
The primary outcome was the detection of gastrointestinal motility disorders (peristaltic activity) in the postoperative period with intermittent USG imaging as a result of decreased opioid consumption during surgery.

研究概览

简要总结

Rapid recovery of postoperative bowel function is one of the important goals of accelerated recovery after surgery (ERAS protocols). Gastrointestinal dysfunctions may occur after general anaesthesia. All these lead to a series of adverse outcomes including prolonged hospital stay, high treatment costs and deterioration of patient comfort.

Percutaneous nephrolithotomy (PNL) is the treatment of choice for sizable and intricate kidney stones. Providing effective postoperative pain control is important in preventing respiratory and thromboembolic complications and ensuring patient comfort as well as shortening the hospital stay. The application of USG-guided nerve blocks for analgesia reduces intraoperative opioid use and provides early recovery of postoperative GI dysfunctions. Retrolaminar block (RLB), have been shown to reduce perioperative opioid consumption. Nerve blocks may relieve inflammation-related gastrointestinal dysfunctions by attenuating postoperative inflammatory responses.

This study aimed to determine the effects of USG-guided retrolaminar block on the postoperative gastrointestinal system in patients undergoing PNL.

详细描述

Rapid recovery of postoperative bowel function is one of the important goals of accelerated recovery after surgery (ERAS protocols). Gastrointestinal dysfunctions such as nausea-vomiting, distension, slowing of intestinal peristalsis, ileus, fatigue, delayed gastric emptying and delayed oral active eating may occur after general anaesthesia. All these lead to a series of adverse outcomes including prolonged hospital stay, high treatment costs and deterioration of patient comfort.

Percutaneous nephrolithotomy (PNL) is the treatment of choice for sizable (>2 cm) and intricate kidney stones. This minimally invasive surgical technique entails the creation of a percutaneous tract through which specialised instruments are inserted to fragment and extract the renal calculi. In the first 24 hours postoperatively, incisional pain is both somatic and visceral in character due to distension in the renal capsule-pelvic- pelvical system and the inserted nephrostomy tube and is carried by the T8-L1 spinal nerves. Blocking the nerves innervating these regions provides an effective analgesia. Providing effective postoperative pain control is important in preventing respiratory and thromboembolic complications and ensuring patient comfort as well as shortening the hospital stay. The application of USG-guided nerve blocks for analgesia reduces intraoperative opioid use and provides early recovery of postoperative GI dysfunctions. Various nerve blocks including retrolaminar block (RLB), erector spina area block (ESPB), and trans abdominal area block (TAPB) have been shown to reduce perioperative opioid consumption. Nerve blocks may relieve inflammation-related gastrointestinal dysfunctions by attenuating postoperative inflammatory responses.

This study aimed to determine the effects of USG-guided retrolaminar block on the postoperative gastrointestinal system in patients undergoing percutaneous nephrolithotomy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Double (Participant, Investigator)

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

  • •ASA (American Society of Anesthesiologists) I-II-III,
  • •18-65 years
  • •unilateral PNL performed under elective conditions

排除标准

  • •body mass index > 40 kg/m2,
  • •inability to understand the pain verbal rating scale and patient-controlled analgesia,
  • •emergency reoperations,
  • •ASA 4 or 5,
  • •drug and alcohol dependence,
  • •drug allergy,
  • •Coagulation disorders,
  • •anatomical abnormalities of the genitourinary system,
  • •gastrointestinal motility disorders,
  • •previous abdominal surgery,
  • •cognitive or psychiatric disorders, mental disorders,
  • •presence of severe systemic disease

研究组 & 干预措施

Group R ( The group of patients who underwent retrolaminar block for analgesia)

Other

Retrolaminar block is a simple and easy to perform paravertebral block. Place of application Intraoperative and postoperative analgesia is achieved by applying local anaesthetic between the lamina of the arcus vertebrae and paraspinous muscles under ultrasound guidance.

干预措施: Group R: retrolaminar block performed group (Other)

Group C

Other

Group C control group without local anaesthetic and block

干预措施: Group C - Placebo (Other)

结局指标

主要结局

The primary outcome was the detection of gastrointestinal motility disorders (peristaltic activity) in the postoperative period with intermittent USG imaging as a result of decreased opioid consumption during surgery.

时间窗: Hour 1, Hour 3, Hour 6, and Hour 12 after surgery

The primary outcome measures were abdominal calculation of Perlas Score (No fluid in the antrum was scored as 0, minimal fluid in the right supine position was scored as 1, and tense antrum in both supine and right supine position was scored as 2) with USG examination after extubation, hour 1, hour 3, hour 6, and hour 12

次要结局

  • postoperative gastrointestinal tract function(Hour 1, Hour 3, Hour 6, Hour 12.)
  • Postoperative analgesia(after extubation, Hour 1, Hour 3 , Hour 6 , and Hour 12.)
  • gastrointestinal tract dysfunction(Hour 1, Hour 3,Hour 6, Hour 12.)

研究者

发起方
Elazıg Fethi Sekin Sehir Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serpil Bayındır

Principal Investigator

Elazıg Fethi Sekin Sehir Hastanesi

研究点 (1)

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