An Open-label Randomized Controlled Trial Comparing the Effect of Conscious Sedation Versus Intrapleural Lignocaine on Pain Score in Patients undergoing Medical Thoracoscopy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded within 20 minutes of the procedure by an independent nursing officer.
研究概览
简要总结
Medical thoracoscopy is commonly used for diagnosing and treating pleural diseases, but it often causes procedural pain and discomfort. Conscious sedation improves patient comfort but carries risks such as respiratory depression and hemodynamic instability. Intrapleural lignocaine, administered via a chest drain, may offer effective analgesia with fewer systemic side effects.
This open-label, randomized controlled trial aims to compare the effect of conscious sedation versus intrapleural lignocaine on pain scores in patients undergoing medical thoracoscopy. Sixty-eight adult patients undergoing thoracoscopy will be randomly assigned in a 1:1 ratio to receive either conscious sedation (midazolam ± fentanyl) or intrapleural lignocaine (3 mg/kg). Pain will be assessed using the Visual Analogue Scale (VAS) within 20 minutes of the procedure (primary outcome).
Secondary outcomes include pain at baseline and 120 minutes post-procedure, patient comfort, complication rates, recovery time, operator satisfaction, and biopsy yield. Statistical analysis will follow the intention-to-treat principle.
The study aims to develop a safer and simpler analgesic strategy for thoracoscopy, potentially enhancing patient safety, comfort, and procedural efficiency, particularly in resource-limited settings.
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 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Indication for diagnostic or therapeutic medical thoracoscopy, Hemodynamically stable patients.
排除标准
- •Any contraindication of thoracoscopy, Allergy or contraindication to lignocaine or sedative drugs, Altered mental status or inability to provide informed consent, Bleeding diathesis or INR more than 1.5, Complex or septated pleural effusion on ultrasound, Cutaneous infection, metastasis or rib fracture around port insertion site, Uncorrectable type 1 respiratory failure, Ongoing type 2 respiratory failure.
结局指标
主要结局
Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded within 20 minutes of the procedure by an independent nursing officer.
时间窗: 20 minutes
次要结局
- To compare recovery times (time to sit, time to ambulation, time to discharge)
- To compare total doses of analgesics and sedatives used between the 2 groups.
- To compare the yield of biopsy between the 2 groups
- Patient satisfaction score (5-point Likert scale).(20 minutes)
- Pain score during thoracoscopy using Visual Analogue Scale (VAS: 0–100), recorded before and within 120 minutes after the procedure by an independent nursing officer.(Before medical thoracoscopy)
- To compare complication rates between the two groups (Hypoventilation, hypoxemia, hemodynamic instability)(During or within 120 minutes of procedure)
- To compare recovery times (time to sit, time to ambulation, time to discharge)(NA)
- To compare operator satisfaction using a numerical rating scale recorded within 20 minutes post-procedure.(Within 20 minutes post-procedure.)
- To compare total doses of analgesics and sedatives used between the 2 groups.(NA)
- To compare the yield of biopsy between the 2 groups(NA)
研究者
Dr Ruchi Dua
All India Institute of Medical Sciences