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临床试验/CTRI/2024/08/072673
CTRI/2024/08/072673尚未招募Unknown

Effectiveness of Ultrasound guided Erector Spinae Plane Block(ESPB) using 0.2 percentage Ropivacaine with Tramadol vs 0.2 percentage Ropivacaine with Dexamethasone vs Conventional intravenous analgesics for post operative pain management in lumbar spine surgeries: A Randomized double blinded study

Dr Midhun Madhavan1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
99
试验地点
1
主要终点
1.Compare the intensity of pain using the Visual Analogue Scale (VAS)scores at different time points postoperatively between the groups

研究概览

简要总结

This prospective randomized double blinded comparative study will be conducted at our institution over a period of 6 months. In this study 90 ASA I and ASA II patients between age 18- 65 years with BMI < 35kg/m2 posted for lumbar spine surgeries included.

A preanaesthetic check-up will be done which included history, general physical examination and checking the vital parameters of the patients such as blood pressure, pulse, respiratory rate and systemic examination, and ASA grading.The patients with major neurological, cardiovascular, metabolic, respiratory, renal disease or coagulation abnormalities will be excluded.

All patients will be given tablet Alprazolam 0.25 mg on the night before surgery for anxiolysis. Bilateral ESPB technique will be fully explained. Written informed consent will be taken from all the patients. In the operating room, all the standard anaesthesia monitors will be attached and induction of general anaesthesia will done using standard anaesthesia technique. All patients will be given inj. Glycopyrrolate, Inj. Midazolam, Inj. Fentanyl, Inj. Loxicard(2%) and induce with Inj. Propofol 2mg/kg followed by Inj. Cisatracurium 0.1 mg/kg to facilitate endotracheal intubation.Anaesthesia will be maintained with oxygen and nitrous oxide (50:50), isoflurane upto 1% v/v and intermittent dose of Inj Cisatracurium 0.05 mg/kg for muscle relaxation. Inj fentanyl will be repeated every 40min to patients in group C. Mechanical ventilation will be adjusted to normocapnia (EtCO2 values of 35–38 mm of Hg). All the patients will be given IV Paracetamol 1gm intraoperatively.

Continuous monitoring of Heart Rate (HR), Blood Pressure (BP), Oxygen Saturation (SpO2) and Electrocardiography (ECG) will be done intraoperatively. At the end of surgery, tracheal extubation will be performed after reversal of neuromuscular blockade with Inj neostigmine 0.05 mg/kg and Inj glycopyrrolate 0.01 mg/kg. The postoperative pain assessment will be performed using VAS score. The VAS score will be recorded at zero hour (being immediate post extubation), 1, 2, 4, 6, 12 and 24 hours. Any complication related to method or drugs will be noted. Injection Dynapar 75mg AQ intravenous (i.v.) will be given as rescue analgesic when patient complains of pain and VAS score was ≥5. Time to first rescue analgesia will also noted. Until first rescue analgesia, no other analgesics will be administered. The patient as well as the anaesthetist assessing pain in the postoperative period will unaware of group allocation.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA1 and ASA2 patients Undergoing upto two level lumbar spine surgeries Surgery duration within 3 hours.

排除标准

  • ASA3 and ASA4 coagulation disorders Severe cardiopulmonary,hepatic or renal diseases Not willing to participate Patient known for opioid dependency Skin infection at local sites Known allergy to anesthetic drugs Surgery duration more than 3 hours.

结局指标

主要结局

1.Compare the intensity of pain using the Visual Analogue Scale (VAS)scores at different time points postoperatively between the groups

时间窗: Immediate post extubation, 1st,2nd,4th,8th,12th and 24 hours.

2.Compare the time at which first rescue rescue analgesia was required in three groups

时间窗: Immediate post extubation, 1st,2nd,4th,8th,12th and 24 hours.

次要结局

未报告次要终点

研究者

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

Dr Midhun Madhavan

Institute of Medical Sciences and SUM Hospital

研究点 (1)

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