The effects of Erector Spinae Plane (ESP) block on post-operative pain management in Percutaneous Nephrolithotomy (PCNL) – a randomized controlled clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To compare the total dose (in mg) of Injection Tramadol required to achieve adequate analgesia (VAS score less than 5) in the total period of 24 hrs post PCNL in the patients receiving ESP block and in the control group.
研究概览
简要总结
A prospective, randomized, placebo-controlled, double-blinded clinical trial to evaluate the efficacy of ipsilateral Erector Spinae Plane block (ESP block) with 20ml 0.25% Inj. Bupivacaine at the L1 vertebral level under ultrasound guidance, performed under general anaesthesia in a prone position before the start of surgery in adult patients undergoing Percutaneous Nephrolithotomy (PCNL) in a tertiary care hospital in India. The placebo control will be injection of 20 ml of Inj. Normal saline (0.9%) instead of Inj. Bupivacaine using an identical procedure. The study will recruit 40 patients over a period of 18 months. The primary outcome variable will be the total dose of intravenous Inj. Tramadol required to maintain adequate analgesia (VAS score less than 5). The secondary outcome variables are the time to first demand of rescue analgesia (VAS score greater than 5); and post operative pain as measured by the Visual Analog Scale (VAS) score and Dynamic Visual Analog Scale (DVAS) score and evaluated at 2hrs, 12hrs and 24hours post surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients (Age >18 years and <60 years) with ASA I to II functional status undergoing PCNL under the Department of Urology in AIIMS, Bhubaneswar.
- •2.Patients who can understand and provide a valid consent for the procedure and also can understand and are willing to report the pain using VAS score.
排除标准
- •1.Patients who are currently suffering from chronic pain syndromes and are already under treatment with daily analgesics.
- •2.Patients in whom multiple nephrostomy tracts have been used, bilateral PCNL is undertaken or in whom conversion of the procedure to open surgery or extension of the normal procedure is required (e.g. second look nephrostomy).
- •3.Patients in whom the anatomy of the anaesthetic injection site is not clearly delineable on ultrasound examination due to any reason.
- •4.Patients who remain intubated/ sedated in the SICU post procedure and cannot participate in reporting the VAS score.
结局指标
主要结局
1.To compare the total dose (in mg) of Injection Tramadol required to achieve adequate analgesia (VAS score less than 5) in the total period of 24 hrs post PCNL in the patients receiving ESP block and in the control group.
时间窗: At the end of 24hrs post surgery
次要结局
- 1.To compare the Visual Analog Scale (VAS) score and the Dynamic Visual Analog Scale (DVAS) score at 2 hrs, 12 hrs and 24 hrs post PCNL in patients receiving ESP block and in the control group.(2hrs, 12hrs and 24hrs post surgery)
- 2.To compare the time to the first demand of rescue analgesia (VAS score ≥ 5) using Inj. Tramadol (an opioid analgesic) post-recovery from general anaesthesia after PCNL in the patients receiving ESP block and in the control group.(Single time point, varies across the study participants, data collected at the end of 24hrs)