“A study to compare the use of ultrasound and conventional blind technique for Epidural neuraxial blockade in orthopaedic joint replacement surgeries : A randomised control trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Rate of successful epidural block on the first needle insertion attempt in both groups with blind conventional technique and preprocedural use of ultrasound
研究概览
简要总结
Aging is of course a biological reality. As population ages, degenerative joint diseases limit the physical activity, hampering their independence and quality of life. Due to increasing life expectancy, sedentary lifestyle, obesity and with advancement in health care infrastructure and technology, joint replacement surgeries are on the rising trend to improve the quality of life. Since decades, anaesthesiologists have striven to perfect identification and cannulation of epidural space using skills learned i.e. knowledge of relevant anatomy and detection of tactile clues during training and early clinical practice.
Patients undergoing joint replacement surgeries increase the challenge for epidural anaesthesia as they are mostly above 50 years of age, having arthritic joints with osteophytic spine, calcified spinal ligaments and narrowed intervertebral spaces. These are mostly obese patients with difficult palpation of anatomical landmarks of spine and spine deformities due to increasing age and gait changes. The positioning for neuraxial blockade is also difficult and suboptimal in these patients as they have lesser compliance and decreased ability to flex the spine.Multiple attempts and difficult access to epidural space is a frequent problem in operating theaters with the standard blind approach in these obese patients with osteophytic spines undergoing joint replacement surgeries. The technical complexities of the epidural catheter insertion can be hazardous for the patient as it increases the risk of procedural complications like accidental dural puncture , failed block and patient discomfort.
The endeavour of this study was to assess the utility of the preprocedural use of an ultrasound technology compared with the conventional blind technique for the epidural catheterisation in obese patients with osteophytic spines undergoing joint replacement surgeries in identifying the correct vertebral space, point of insertion of the epidural needle, depth of the epidural space and its accuracy with respect to success rate of epidural catheterisation in the first attempt vis a vis the blind approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 51.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergoing orthopaedic joint replacement surgeries 2.Patients with age more than 50 years 3.ASA I-III patients 4.Patients able to provide own consent 5.Patients with BMI ≥ 30 kg/m2.
排除标准
- •V patients 2.Patients with known hypersensitivity to local anaesthetics 3.Patients with bleeding disorders 4.Patients on anticoagulants 5.Patients with infection at neuraxial blockade site.
结局指标
主要结局
Rate of successful epidural block on the first needle insertion attempt in both groups with blind conventional technique and preprocedural use of ultrasound
时间窗: zero seconds /minutes or few seconds after local infilteration
次要结局
- Number of needle passes (insertion and redirection attempts) required for successful epidural block(A needle redirection attempt was defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient‟s skin.)
- Correlation of depth of the epidural space measured with an Ultrasound and LOR technique.(zero seconds / minutes or few seconds after local infilteration)
- The efficacy of the epidural component of combined spinal epidural anaesthesia(determined by pain relief (VAS) after 30 minutes of initiation of epidural infusion postoperatively after return of toe movements and patient satisfaction after 5 hours of epidural catheter insertion.These were the end points of the study.)
- Number of needle insertion attempts required for successful epidural block(A needle insertion attempt was defined as needle insertion preceded by complete withdrawal of the Tuohy‟s needle from the patient‟s skin.)
- Patient Satisfaction Score(3.5,4,4.5 and 5 hours after insertion of epidural catheter)
- Number of Accidental Dural Puncture by Tuohys needle of Combined Spinal Epidural set(at Zero second /minutes or few seconds after local infilteration)
- Visual Analog Scale(10.20 and 30 minutes after initiation of Epidural Infusion postoperatively)
- Number of failed block(A failed epidural was defined as a block providing inadequate analgesia (VAS ≥ 4/10) despite the following sequential steps:)