Comparing Pain Outcomes Following Preemptive Regenerative Peripheral Nerve Interface (RPNI) Versus Traction Neurectomy in Post-Traumatic Lower Limb Amputations- A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
研究概览
简要总结
This study is required to address the ongoing challenge of chronic post-amputation pain, which significantly impairs rehabilitation and quality of life in patients undergoing lower limb amputation following trauma. Traditional traction neurectomy often fails to prevent neuroma formation and neuropathic pain.
The Regenerative Peripheral Nerve Interface (RPNI) technique has shown promise in promoting physiologic nerve healing and reducing pain, but robust comparative data in post-traumatic cases are lacking.
By comparing pain outcomes between pre-emptive RPNI and traction neurectomy through a randomized controlled trial, this study aims to provide evidence-based guidance to improve surgical outcomes in trauma care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients undergoing transfemoral/transtibial amputation
- •Hemodynamically stable patients
- •Patients between the ages of 18-65 years.
排除标准
- •Patients who do not consent to the study
- •Proximal injury to the sciatic nerve, quadriplegia and paraplegia
- •Patients with severe or moderate head injury, unable to follow directions and comply with treatment
- •Patients who need ventilator support for more than 48-72 hours
- •Pregnant females
- •Known psychiatry illness Post randomisation exclusion • Patient who requires stump revision or debridement after RPNI will be excluded • Death of patients, if any.
- •• Intensive Care Unit (ICU) stay of more than 48-72 hours.
研究者
Dr Abhijit B R
JPNATC, AIIMS, New Delhi