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临床试验/CTRI/2024/04/065589
CTRI/2024/04/065589尚未招募不适用

COMPARISON OF UNILATERAL ERECTOR SPINAE PLANE BLOCK AND LOCAL INFILTRATION OF THE INCISION SITE FOR POSTOPERATIVE ANALGESIA IN PERCUTANEOUS NEPHROLITHOTOMY – A RANDOMISED COMPARATIVE STUDY

Dr Neha gupta1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
To assess the duration of postoperative analgesia of USG guided ESPB compared

研究概览

简要总结

Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical technique and a gold standard technique for the removal of large (>20 mm) renal and upper ureteric calculi. However, it may be associated with substantial postoperative pain due to stretching of the renal capsule the parenchymal tract and from the incision of the skin, subcutaneous tissue, muscle layer, and the presence of nephrostomy tube. Several modalities of analgesia have been tried to decrease post operative pain. The analgesic modalities that have been tried include: several systemic analgesics [opioids, non-steroidal anti-inflammatory drugs (NSAIDs)], paracetamol, and regional techniques (subcutaneous infiltration, peritubal infiltration, intercostal nerve block (ICNB), paravertebral block (PVB), epidural analgesia] that have been tried for providing postoperative analgesia. While NSAIDs can have potential systemic side

effects in these patients with possible kidney injury, other regional techniques like epidural and paravertebral blocks can be pretty invasive. Patients posted for PCNL surgery often have suboptimal renal function and non-steroidal anti-inflammatory drugs (NSAID) are potentially nephrotoxic. Therefore novel regional anesthetic techniques that would provide optimal pain control without significant adverse effects need to be explored.

Erector Spinae Plane Block (ESPB) is a novel analgesic technique which was first described in 2016 for thoracic neuropathic pain. It has subsequently found efficacious for acute pain control after surgeries like Mastectomies, Percutaneous Nephrolithotomy, Lumbar spine surgeries, Laparoscopic Cholecystectomy. ESPB involves injection of the local anaesthetic into the plane between the erector spinae muscle sheath and the transverse process of the vertebra. When injected, the injectate spreads cranio-caudally

resulting in the blockage of multiple vertebral levels. ESPB affects both the ventral and dorsal rami, leading to blockage of both visceral and somatic pain.

Local anesthetic infiltration of incision site is another novel modality of pain relief in PCNL surgery (skin, subcutaneous tissue, renal capsule, and parenchymal tract) is done with local anesthetic drugs. This can produce significant reduction of pain as assessed by visual analog scale (VAS) score with less demand for rescue analgesia.

This study was designed to compare the efficacy of USG guided ESPB with local infiltration at the incision site in providing postoperative analgesia following PCNL.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients posted for Percutaneous Nephrolithotomy Surgeries.
  • Age ≥ 18 years.
  • American Society of Anaesthesiologists (ASA) class I and II patients.

排除标准

  • 1.Patients with history of known allergy to local anesthetic agent
  • Patients who have contraindications to peripheral nerve blocks
  • Infection at the site of injection
  • Body mass index more than 35 kg/m2
  • Drug abuse, sepsis, bacteremia physiological or other emotional problems.

结局指标

主要结局

To assess the duration of postoperative analgesia of USG guided ESPB compared

时间窗: 24 hours after surgery

with surgical site local infiltration in patients undergoing PCNL

时间窗: 24 hours after surgery

次要结局

  • 1. To compare the total need of rescue analgesia in first 24 hours.(2. Incidence of postoperative nausea and vomiting)

研究者

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

Dr Neha Gupta

Dr. B. R. Ambedkar Medical College and Hospital

研究点 (1)

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