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临床试验/CTRI/2024/10/074599
CTRI/2024/10/074599尚未招募2/3 期

The effect of posterior quadratus lumborum block for intra and post operative analgesia in pediatric patients undergoing renal transplant surgery-a pilot study

Ratish1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
1.Time to first requirement of analgesia after tracheal extubation

研究概览

简要总结

Main purpose of quadratus lumborum block is to provide adequate analgesia for pediatric patients. The utility of QLB has been shown in adults undergoing renal transplant surgery. Children with CKD would understandably be at a disadvantage when undergoing surgery. The fear of opioid overdose, greater risk with neuraxial blockade and inability to use NSAIDS places them at a disadvantage when it comes to adequate perioperative analgesia. This study aims to explore the analgesic efficacy of posterior QLB in children undergoing renal transplant surgery.

Pre-operative evaluation

Detailed PAC

Informed written parental consent.

Investigations: Serum sodium, potassium, calcium, complete blood count, blood urea, serum creatinine and chest x ray.

 Intra operative care

Patients will be randomized into 2 groups (Standard and Quadratus lumborum block group)

ASA standard monitors like pulse oximeter, NIBP, electrocardiography will be attached and baseline values of pulse rate, SpO2, blood pressure, ECG will be recorded.

Anaesthesia will be induced after securing IV cannula.

Intravenous isotonic fluid (Ringer’s Lactate) will be started.

Intravenous etomidate in the dose of 0.3-0.4 mg/kg or propofol 2-3 mg/kg along with fentanyl in the dose of 2-3 mcg/kg will be used for induction of anesthesia. Muscle relaxants, atracurium 0.5 mg/kg, will be injected and patient will be intubated with appropriate sized endotracheal tube

Quadratus lumborum block will be given as per group allocation before surgical incision.

A linear multi-frequency 6-13 MHz transducer probe wrapped with a sterilized sheath will be utilized for ultrasound guided QLB.

The child will be positioned in a lateral position with operative side up. The probe will be placed above the iliac crest where external, internal oblique, and transversus abdominis muscles could be seen; the probe will be then advanced posteriorly till the quadratus lumborum (QL) muscle is seen deep within the latissimus dorsi. After that, a 22-gauge, 60 mm length Sono Plex echogenic needle will be advanced in-plane from an anterior to posterior direction until the needle tip is positioned between the posterior border of QL and its fascia. 0.5ml-1ml saline will be injected to confirm the needle tip’s position. This will be followed by injection of 0.5ml/kg of 0.2% ropivacaine after negative aspiration rules out intravascular placement.

Proper placement should result in spread of local anesthetic through the middle TLF layer and into the interfascial triangle. Surgery will be allowed to start once the patient is turned to supine position and all the monitors are in place and the baseline values have been taken. Intraoperatively, whenever the hemodynamics suggest analgesic requirement, fentanyl 1mcg/kg will be given intravenously. All patients will receive injection paracetamol 15mg/kg.

  Post operative care

After completion of surgery, patient will be extubated and shifted to Transplant Intensive Care Unit (TICU)

An anesthesiologist blinded to group allocation will monitor the children in the postoperative ward for analgesic efficacy with NRS score.

At the first request of analgesia or if NRS ³4 patients will be given fentanyl 1mcg/kg and an infusion of fentanyl will be started at 0.25-1mcg/kg/hr to maintain NRS <4.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

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

入选标准

  • 1.Age between 7 and 18 years Undergoing Renal transplant 2.Both genders.

排除标准

  • 1.Non consenting Patient or parent 2.Coagulation disorder 3.Allergy to Local Anaesthetics 4.Pre Existing Peripheral neuropathies 5.Failed tracheal extubation.

结局指标

主要结局

1.Time to first requirement of analgesia after tracheal extubation

时间窗: 1st, 2nd ,4th ,6th,12th and 24th hour after extubation

次要结局

  • 1.NRS at 1st,2nd,4th,6th,12th and 24th hour postoperatively

研究者

发起方
Ratish
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR. RATISH C

AIIMS NEW DELHI

研究点 (1)

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