CTRI/2025/08/092868尚未招募不适用
Effect of noise cancellation headphones during total hip arthroplasty under spinal anaesthesia on postoperative pain; a randomized trial controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Difference between mean of highest pain scores in the first 24 hours after surgery, measured using a 11-point numeric rating scale (NRS)in both groups.
研究概览
简要总结
Single-blind, randomized controlled pilot study of 70 adults undergoing elective total hip arthroplasty under spinal anaesthesia to assess the effect of noise-cancellation headphones on postoperative pain. Primary outcome: highest NRS pain score in first 24 h. Secondary outcomes: pain scores at set intervals, time to first analgesic, total analgesic use, sensory/motor block duration, QoR-15 at 24 h, and intraoperative sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor 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
- •Patients aged 18 to 65 years with American Society of Anaesthesiologists (ASA) physical status I to III.
排除标准
- •Patients with hearing impairment or use of hearing aids; chronic pain syndromes or regular opioid analgesic use in the last three months; neurological disorders including dementia, Parkinson’s disease, or stroke; psychiatric illness such as major depression, schizophrenia, or severe anxiety; contraindications to spinal anaesthesia such as coagulopathy, infection at injection site, or spinal deformities; BMI greater than 35 kg/m²; uncontrolled cardiovascular disease such as severe hypertension, recent myocardial infarction, or heart failure.
结局指标
主要结局
Difference between mean of highest pain scores in the first 24 hours after surgery, measured using a 11-point numeric rating scale (NRS)in both groups.
时间窗: First 24 hours after surgery.
次要结局
- Mean post operative pain scores using NRS at 4, 8, 12, and 24 hours after surgery.(4, 8, 12, and 24 hours after surgery.)
- Mean time to requirement of first postoperative analgesic.(Within first 24 hours after surgery.)
- Mean analgesic consumption over first 24 hrs postoperatively.(First 24 hours after surgery.)
- Mean duration of sensory blockade and motor blockade of spinal anaesthesia.(From administration of spinal anaesthesia until complete recovery of sensory and motor function.)
- Mean quality of Recovery -15 (QoR- 15) scores at 24 hours.(24 hours after surgery.)
- Mean intraoperative Bispectral Index Scores (BIS).(During intraoperative period.)
研究者
Arun Prasannan
Maulana Azad Medical College
研究点 (1)
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