A Randomised Prospective comparative study to assess the post operative analgesic effect of Erector Spinae Plane Block with bupivacaine adjuvant Dexamethasone Versus I.V. Tramadol after Percutaneous Nephrolithotomy Under spinal anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Mean VAS score
研究概览
简要总结
Traditionally, systemic opioids like intravenous tramadol have been employed for postoperative pain management in PCNL due to their centrally acting analgesic properties. However, opioid-based analgesia is not without drawbacks—it often brings along a host of undesirable side effects such as nausea, vomiting, sedation, respiratory depression, and delayed mobilization, which can hinder early recovery. In recent years, the quest for safer and more effective analgesic alternatives has led to increased interest in regional anesthesia techniques, especially interfascial plane blocks. Among these, the Erector Spinae Plane Block (ESPB), first described in 2016, has gained attention for its simplicity, safety profile, and ability to provide both somatic and visceral analgesia. By depositing local anesthetic in the fascial plane deep to the erector spinae muscle at the level of the transverse process, ESPB facilitates diffusion of the drug to the dorsal and ventral rami of spinal nerves, thereby covering multiple dermatomes. Its application in PCNL has been explored due to the anatomical proximity of the surgical site to the thoracolumbar segments innervating the kidney.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient scheduled for elective percutaneous nephrolithotomy under spinal anaesthesia 2.ASA GRADING 1-2
- •Patients willing to give informed written consent.
排除标准
- •Patient should not be part of other study
- •Non co-operative patient
- •Localised infection at the proposed site of injection
- •Psychiatric illness
- •Coagulation abnormalities
- •Known allergy to local anaesthetics.
结局指标
主要结局
1. Mean VAS score
时间窗: At 2 hour | At 4 hour | At 6 hour | At 8 hour | At 10 hour | At 12 hour | At 16 hour | At 18 hour | At 20 hour | At 24 hour
2. Mean time of first rescue analgesia
时间窗: At 2 hour | At 4 hour | At 6 hour | At 8 hour | At 10 hour | At 12 hour | At 16 hour | At 18 hour | At 20 hour | At 24 hour
3. Mean total opioid consumption
时间窗: At 2 hour | At 4 hour | At 6 hour | At 8 hour | At 10 hour | At 12 hour | At 16 hour | At 18 hour | At 20 hour | At 24 hour
次要结局
- 1. Mean hemodynamic variables(2. Percentage of block related complication)
研究者
Dr Varsha Kothari
SMS MEDICAL COLLEGE