Comparison Of Intrasnasal Tapentadol Versus Intravenous Tramadol For Post Operative Analgesia In Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To assess reduction in pain scores following Tapentadol Nasal Spray and IV Tramadol for Postoperative pain management following lower limb orthopaedic surgeries
研究概览
简要总结
The study titled “Comparison of Intranasal Tapentadol versus Intravenous Tramadol for Postoperative Analgesia in Lower Limb Orthopaedic Surgeries under Spinal Anaesthesia” is a prospective observational study aimed at evaluating the effectiveness of intranasal tapentadol compared to intravenous tramadol in controlling postoperative pain.
Background: Postoperative pain management is crucial for faster recovery and early mobilization. Tapentadol offers potent analgesia with fewer side effects due to its dual mechanism of action. Intranasal delivery provides rapid onset and better bioavailability.
Aim: To compare the analgesic efficacy of intranasal tapentadol nasal spray and intravenous tramadol.
Objectives:
Primary: To assess reduction in pain scores.
Secondary: To evaluate adverse effects, early mobilization, and patient satisfaction.
Methods:
Conducted at K.S. Hegde Medical Academy (2025–2027).
Sample size: 86 patients.
Inclusion: Adults (18–60 yrs) undergoing elective lower limb orthopedic surgeries under spinal anesthesia.
Two groups: Tapentadol NS vs IV Tramadol.
Pain scores assessed using VAS at multiple intervals up to 48 hours.
Adverse effects and rescue analgesic use monitored.
Statistical Analysis: Unpaired t-test, Mann–Whitney U, Chi-square, significance set at p < 0.05.
Expected Outcome: Intranasal tapentadol is anticipated to provide faster onset, better pain control, fewer side effects, and improved early mobilization compared to IV tramadol.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Asa physical status classification grade 1 to 3 Patients undergoing elective lower limb orthopedic surgeries under spinal anaesthesia.
排除标准
- 未提供
结局指标
主要结局
To assess reduction in pain scores following Tapentadol Nasal Spray and IV Tramadol for Postoperative pain management following lower limb orthopaedic surgeries
时间窗: 1hr ,2hr,4hr,6hrs for first 6hrs and every 6hrs for 48hrs
次要结局
- To assess adverse effects, the impact on early mobilization & patient satisfaction after 48hrs
研究者
Bhuvaneswari prasad k
Kshegde medical academy