Development And Evaluation Of Clinical Efficacy Of Vijaya Patra Transdermal Patch In Post Operative Pain Management
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post operative Pain Reduction and sustained analgesic effect of the transdermal patch over time.
研究概览
简要总结
Post-operative pain is a significant concern in surgical practice, requiring effective management to enhance recovery and patient comfort. Conventional analgesics, such as opioids and NSAIDs, pose risks of adverse effects and long-term complications. This study aims to evaluate the clinical efficacy and safety of the Vijaya Patra (Cannabis sativa) transdermal patch as an alternative approach for post-operative pain management.
The study will assess pain reduction (VAS scale), opioid/NSAID consumption, duration of analgesia, patient satisfaction, and adverse effects over five days post-surgery. Transdermal drug delivery offers advantages such as sustained release, precise dosing, and reduced systemic side effects. The findings will help establish the potential role of cannabis-based transdermal patches in improving post-operative pain management and reducing reliance on conventional analgesics Given the limited clinical evidence on cannabis-based transdermal patches in post-operative settings, this research will contribute valuable insights into their role as a safe and effective analgesic alternative.
Hence the need and uniqueness of study.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients undergone any surgery by Local or spinal anesthesia, complaining of pain, irrespective of their gender & Occupation.
- •2.Patients who are above 18 years and below 60 years of age.
排除标准
- •1.Patients who are regularly taking anti-epileptic, anti-depressant or anti-psychotic drugs & alcohol.
- •2.Pregnant or breastfeeding mothers.
- •3.Patients who are taking NSAIDs regularly for other conditions.
- •4.Patients not giving consent for enrollment in the study.
- •5.Known allergy to medical cannabis, or patches ingredients, history of severe liver or kidney disease or other serious psychiatric diseases.
结局指标
主要结局
Post operative Pain Reduction and sustained analgesic effect of the transdermal patch over time.
时间窗: from commencement of pain reduction in between 1 hours, 6 hours ,12 hours ,24 hours postoperatively for 5 days post operative days
次要结局
- the effect on early ambulation and return to daily activities and Assessing ease of use, adherence, and patient preference compared to controlled group medicine(from commencement of pain reduction in between 1 hours, 6 hours ,12 hours ,24 hours postoperatively for 5 days post operative days)
研究者
Dr Nikhil Nimba Girase
Parul Institute of Ayurved