跳至主要内容
临床试验/CTRI/2025/08/093538
CTRI/2025/08/093538招募中不适用

Comparison of paramedian vs paraspinous approach for subarachnoid block in elderly patients with degenerative spine disease undergoing total knee arthroplasty

Not applicable1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
To compare the number of attempts required for successful sub arachnoid block with paramedian and paraspinous approaches in elderly patients with degenerative spine disease.

研究概览

简要总结

Total Knee Arthroplasty (TKA) is a common surgical procedure performed to alleviate pain and improve functionality in patients suffering from knee osteoarthritis, particularly in the elderly population. With increasing age, patients often present with a variety of comorbid conditions, one of which is degenerative spine disease (DSD). This condition can lead to anatomical changes and challenges in achieving optimal spinal anesthesia for procedures such as TKA.

Spinal anesthesia, specifically subarachnoid block (SAB), is a widely utilized technique for TKA due to its advantages of reliable muscle relaxation, effective analgesia, and reduced systemic complications compared to general anesthesia. However, elderly patients with DSD present a unique challenge due to altered spinal anatomy, such as narrowed intervertebral spaces and osteophyte formation, which may complicate needle placement for the block. In such cases, the choice of approach for SAB becomes critical to minimize complications and ensure a successful block.

The two commonly used approaches for spinal anesthesia are the paramedian and the paraspinous techniques. While both have been described in the literature, the comparative efficacy, safety, and ease of performing these approaches in elderly patients with DSD have not been extensively studied. This study aims to evaluate and compare the paramedian and paraspinous approaches for SAB in elderly patients undergoing TKA, specifically those with degenerative spine changes

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 65 years or older.
  • Diagnosis of degenerative spine disease confirmed by imaging.
  • ASA Physical Status Classification 1-
  • Scheduled for a surgical procedure suitable for subarachnoid block.

排除标准

  • Known contraindications to subarachnoid block.
  • Coagulopathy or anticoagulant therapy.
  • Severe spinal deformity beyond degenerative changes.
  • Known allergy to local anesthetics.

结局指标

主要结局

To compare the number of attempts required for successful sub arachnoid block with paramedian and paraspinous approaches in elderly patients with degenerative spine disease.

时间窗: 0-10 minutes

次要结局

  • To assess procedure time, patient comfort, & incidence of complications (PDPH, Backache) in both approaches.(day 1 & day 3 for PDPH & Bachache)

研究者

申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

NEHA GARG

AIIMS

研究点 (1)

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