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临床试验/CTRI/2023/09/058021
CTRI/2023/09/058021尚未招募4 期

Comparative Randomized study of Erector Spinae Plane Block (ESPB) v/s Quadratus Lumborum Block (QLB) for post-operative analgesia in patients undergoing Percutaneous Nephrolithotomy (PCNL) surgery

Teerthanker Mahaveer Medical College and research Centre1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
VAS (Visual Analogue Score)

研究概览

简要总结

After getting approval from Institutional Ethical Committee (IEC), those  patients who are fit in inclusion criteria will be included in our study.

Two groups both including 35 patients will be created and randomization will be done using chit and box method

Group E will undergo ESPB, Group Q will undergo QLB

Spinal anaesthesia will be given as per the institution’s protocol.

After surgery, QLB or ESPB will be performed under the guidance of a ultrasound machine (curvilinear probe) with 10 cm echogenic needle and 30 ml 0.25% bupivacaine will be injected.

The patient will be shifted to PACU and standard analgesia (1 gm PCM 8 hrly i/v) will be given as per standard institute protocol.

VAS score and haemodynamic parameter will be assessed at the end of surgery every hr for the first 6hrs then after12hrs, 18hrs, and 24hrs.

VAS >4 will be given rescue analgesia in form of I/V tramadol (1.5mg/kg).

Total rescue analgesic consumption in 24 hrs and complications will be noted.

Data will be analyzed using the appropriate statistical method.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator 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

  • Patient given informed and written consent 2) ASA physical status I-II 3) Body mass index 18.5-22.9 kg/m2.

排除标准

  • Bleeding disorders 2) Skin lesions at site 3) Infections at site of proposed needle insertion 4) Allergic to local anaesthetics 5) Patient converted to GA intraoperatively.

结局指标

主要结局

VAS (Visual Analogue Score)

时间窗: 0, 1, 2, 3, 4, 5, 6, 12, 18, 24 Hrs

次要结局

  • Hemodynamics (Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean arterial pressure, SPO2)(0, 15, 30, 45, 60, 90 Mins)

研究者

发起方
Teerthanker Mahaveer Medical College and research Centre
申办方类型
Private medical college

研究点 (1)

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