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临床试验/CTRI/2025/11/097544
CTRI/2025/11/097544尚未招募3 期

Comparison of ultrasound guided single level paravertebral block with peritubal infiltration for postoperative analgesia in patients undergoing percutaneous nephrolithotomy.

ABVIMS and DR RML HOSPITAL1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Total tramadol consumption

研究概览

简要总结

This randomized comparative study aims to evaluate the postoperative analgesic efficacy of ultrasound-guided single-level thoracic paravertebral block (PVB) versus peritubal infiltration (PTI) in patients undergoing percutaneous nephrolithotomy (PCNL) under general anesthesia. PCNL, although minimally invasive, is often associated with moderate to severe postoperative pain due to renal capsular stretch, pelvicalyceal system distension, and nephrostomy tube irritation. Effective pain control is crucial to enhance recovery and reduce opioid-related side effects.

A total of 30 adult patients (aged 18–65 years) with ASA I–II undergoing elective PCNL will be enrolled and randomized into two equal groups. Group PV will receive a single-level ultrasound-guided PVB at the T8–T9 level with 20 mL of 0.25% bupivacaine. Group PT will receive four-quadrant peritubal infiltration with the same volume and concentration of bupivacaine under fluoroscopic guidance. All patients will receive standard general anesthesia and postoperative monitoring.

The primary outcome is total tramadol consumption in the first 24 hours postoperatively. Secondary outcomes include pain scores using the Numerical Rating Scale (NRS) at multiple time points, time to first rescue analgesia, hemodynamic parameters, block administration time, and any complications.

This study seeks to identify which of the two regional analgesia techniques provides superior pain control with minimal side effects, potentially optimizing postoperative care in PCNL patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American society of anaesthesiologists class I and class II patients.

排除标准

  • Patients allergic to local anaesthetics.
  • Pregnant patients.
  • Patients with neurological disorders like multiple sclerosis, parkinson’s etc.
  • that may affect pain perception.
  • Patients with psychiatric illnesses that may cause difficulty in pain assessment.

结局指标

主要结局

Total tramadol consumption

时间窗: In 24 hours post operatively

次要结局

  • Complications of blocks, if any
  • Time taken to give two blocks
  • Post operative pain scores using NRS(At 0,1,2,4,8, 12 and24 hours post operatively)
  • Time for first rescue analgesic request.
  • Haemodynamic parameters(heart rate, systolic blood pressure, diastolic, blood pressure, mean arterial pressure)(At zero, one, two, four, eight, twelve and twenty four hours post operatively)

研究者

发起方
ABVIMS and DR RML HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kartik

ABVIMS and Dr. RML HOSPITAL

研究点 (1)

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