Evaluation of landmark guided erector spinae plane block versus local anaesthetic infiltration of the surgical site for post operative analgesia in patients undergoing Percutaneous Nephrolithotomy surgery: A comparative study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To compare the time at which the first rescue analgesic dose of Inj. Tramadol 50 mg IV is required by patients with postoperative visual analogue scale (VAS) pain scores of ≥ 4 in the ESPB and LAI groups.
研究概览
简要总结
Background:
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for kidney stones over 2 cm, such as staghorn calculi, particularly when other treatments fail. Despite its advantages, PCNL may cause significant postoperative pain due to renal capsule dilation and nephrostomy tube distension, leading to complications like nausea and vomiting. Effective postoperative analgesia is crucial for enhancing patient recovery, promoting early mobilization, and preventing complications like deep vein thrombosis. Various analgesic strategies, including systemic opioids, NSAIDs, and nerve blocks, have been utilized, but some pose risks. The erector spinae plane block (ESPB) is a newer method of pain management that involves targeting the erector spinae muscle to anesthetize multiple dermatomes. Although its potential is recognized, research into its effectiveness, particularly in PCNL, remains limited. This study aims to compare the efficacy of ESPB using landmark guidance against local anesthetic infiltration for postoperative analgesia in PCNL, evaluating the timing of the first analgesic dose and overall analgesic consumption in the first 24 hours, alongside monitoring for postoperative nausea and local anesthetic toxicity.
Purpose of trial:
This trial is being conducted as part of a postgraduate medical research project.
Reason for selection of topic:
· Most of the research and publications have focused on its use in thoracic surgery, with a few exceptions in abdominal surgeries. In my study, I would like to focus on percutaneous nephrolithotomy surgery.
· Few studies have been conducted on erector spinae plane blocks for percutaneous nephrolithotomies by using either USG-guided (or) fluoroscopy-guided erector spinae plane blocks with Inj Bupivacaine as a local anaesthetic.
· I chose landmark-guided Erector spinae plane block and Inj Ropivacaine for my study. I want to compare the effectiveness of landmark-guided ESP blocks with local anaesthetic infiltration at the surgical site with Inj. Ropivacaine after PCNL surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with ASA physical status 1 and 2 of either gender.
- •Age 18-65 years.
- •Patients posted for unilateral percutaneous nephrolithotomy surgery under general anesthesia, with endotracheal intubation.
排除标准
- •Known allergies to the drugs used.
- •Patients using analgesic drugs before surgery or posted for emergency or urgent surgery.
- •Patients with cognitive impairment or mental retardation.
- •Pregnant females.
- •Patients with history of alcohol or drug addiction.
- •Coagulopathy.
结局指标
主要结局
To compare the time at which the first rescue analgesic dose of Inj. Tramadol 50 mg IV is required by patients with postoperative visual analogue scale (VAS) pain scores of ≥ 4 in the ESPB and LAI groups.
时间窗: 24 hours
次要结局
- To study the incidence of post-operative nausea and vomiting (PONV) in ESPB & LAI groups within the first 24 hours after surgery(24 hours)
研究者
Dr Meela Ranjith Kumar
Krishna institute of Medical Sciences