A Randomized Controlled Trial Comparing Postoperative Pain and Analgesia Requirement Between Tubeless and Standard Percutaneous Nephrolithotomy (PCNL)
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
- Stone-Free Rate (SFR)
研究概览
简要总结
Percutaneous nephrolithotomy (PCNL) is the surgery usually done to break down kidney stones that are larger than 1.5 cm. Placing a nephrostomy tube after the surgery to drain urine is a common aspect of traditional PCNL. This tube placement is associated with post-op pain and discomfort. In tubeless PCNL, the nephrostomy tube is not placed, which may lessen pain and speed up recovery. In this randomized controlled trial, the primary objective is to assess the pain and analgesia requirements of patients at different time points after surgery who have undergone a standard PCNL or a tubeless PCNL. Secondary parameters will be recorded, like surgical time, duration of hospital stay, and time interval before the first complaint of pain. Results from this research will offer advice about whether tubeless PCNL can be considered a safe and patient-friendly option as compared to the standard method.
详细描述
Percutaneous nephrolithotomy (PCNL) is the main surgical option for the management of big kidney stones. Traditionally, a nephrostomy tube is inserted at the end of the operation to allow drainage and provide the opportunity for re-intervention. On the other hand, nephrostomy tubes are believed to cause more postoperative pain and patient discomfort.
Tubeless PCNL, which means that the nephrostomy tube is left out while internal drainage is maintained with a ureteral stent, has been suggested as a method to lessen postoperative morbidity. Although more and more studies indicate that it is safe and effective, some people are still not sure because of possible complications, for example, urinary leakage and the need for additional surgery.
The research was set up as a prospective randomized controlled trial at a tertiary care hospital. Researchers recruited and randomized sixty (60) patients aged 18 to 80 years with renal stones greater than 1.5 cm into two groups: standard PCNL and tubeless PCNL. The randomization was done using the SNOSE method, which uses sequentially numbered opaque sealed envelopes.
General anesthesia was used during all operations. Two consultant urologists who have wide experience in this field performed the operations. While the standard PCNL group ended up with a nephrostomy tube at the end of the operation, the tubeless PCNL group did not get any nephrostomy tube.
The main variable was postoperative pain intensity, which was measured on a visual analogue scale (VAS) at 6, 12, and 24 hours. Other variables were operative time, time to first pain complaint, length of hospital stay, and analgesia requirements.
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
- None
盲法说明
Due to the nature of the surgical intervention, blinding participants, care providers, and outcome assessors was not feasible.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •Renal stones greater than 1.5 cm
- •Schedule for percutaneous nephrolithotomy (PCNL)
- •Ability to provide informed consent
排除标准
- •Congenital anatomical renal abnormalities
- •Known bleeding disorders
- •Pelvicalyceal system perforation
- •Refusal or inability to provide informed consent
研究组 & 干预措施
Standard PCNL
Patients undergo standard percutaneous nephrolithotomy (PCNL) with placement of a nephrostomy tube at the end of the procedure.
干预措施: Standard Percutaneous Nephrolithotomy (Standard PCNL) (Procedure)
Tubeless PCNL
Patients undergo tubeless percutaneous nephrolithotomy (PCNL) without placement of a nephrostomy tube.
干预措施: Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL) (Procedure)
结局指标
主要结局
Stone-Free Rate (SFR)
时间窗: 4 weeks postoperatively
Proportion of patients with no residual renal stones or clinically insignificant fragments (\<4 mm) confirmed on postoperative imaging.
Postoperative Pain Score
时间窗: 6 hours, 12 hours, and 24 hours postoperatively.
Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 mm (no pain) to 100 mm (worst imaginable pain), where higher scores indicate worse pain.
次要结局
- Operative Time(During the surgical procedure (from skin incision to completion of procedure))
- Time to First Pain Complaint(From end of surgery to first reported pain, assessed up to 24 hours postoperatively)
- Length of Hospital Stay(From admission to discharge, assessed up to 5 days)
- Analgesia Requirement(From end of surgery up to 24 hours postoperatively)
研究者
Dr. Mubeen Iqbal
Consultant
Indus Hospital and Health Network