Analgestic advantage of surgical placed perineural catheter for below knee amputation- A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be the successful placement of perineural catheters in patients undergoing below knee amputation. The catheter will be considered successfully placed if it provides adequate sensory coverage for pain relief and is free from any immediate complications after the procedure.
研究概览
简要总结
Lower-extremity amputation is a critical surgical procedure performed when the tissues of the leg and foot become nonviable or dysfunctional due to various reasons, such as ischemia, infection, trauma, or malignancy. Despite advancements in pain management, postoperative pain after major lower limb amputation remains a significant challenge for both clinicians and patients. The postoperative pain plays a crucial role in determining overall patient satisfaction with their surgical experience.
The use of opioids for pain relief is common, but they come with side effects and potential complications, such as, respiratory depression, pruritus, nausea, vomiting, hemodynamic changesbradycardia, hypotension, to name a few, leading to increased hospital costs and prolonged stay. To improve postoperative pain management, the American Society of Anaesthesiologists(ASA) recommends the use of peripheral wound catheters (PWCs) with local anesthetics. Perineural catheters (PNCs) are a type of PWC specifically placed near major nerves to allow continuous infusion of local anesthetics directly into the perineural space. The study aims to investigate the analgesic advantage of surgically placed PNCs for Below-Knee Amputation (BKA), providing valuable insights into the efficacy and feasibility of this postoperative analgesic technique.
All patients fulfilling the eligible criteria will be recruited into the study after obtaining informed consent on the day before the surgery. PNC will be placed surgically intraoperatively. As per the current protocol, they will be administered intermittent boluses of local anaesthetics (via the catheter), either with an automated bolus pump or manually injections. The postoperative pain assessment will be carried out using the Numerical Rating Scale (NRS) score by the pain team.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with ASA-I to III, physical status, aged 18 years or older
- •Patients undergoing elective or emergency major below knee amputation (BKA)
- •Patients capable of assessing pain using a Numerical Rating Scale (NRS).
排除标准
- •Patients with necrotizing fasciitis needing BKA
- •Patients undergoing Above Knee Amputation (AKA) or any other level of amputation (e.g., digital, metatarsal, tarsal, disarticulation of the hip)
- •Patients with an allergy or intolerance to any substances in the perineural catheter (PNC) or local anesthetic agents, or patients chronically taking class IB antiarrhythmic agents or local anesthetic agents in the form of transdermal patches.
- •Patients expected to be managed in the intensive care unit postoperatively and be sedated for more than 24 hours.
结局指标
主要结局
The primary outcome of the study will be the successful placement of perineural catheters in patients undergoing below knee amputation. The catheter will be considered successfully placed if it provides adequate sensory coverage for pain relief and is free from any immediate complications after the procedure.
时间窗: Pre-op (Baseline), post-op at 8th hr, 16th hr, 24th hr, 32nd hr, 40th hr,48th hr,56th hr, 64th hr,72nd hr.
次要结局
- Advantage & Pain Relief: The study will evaluate the analgesic advantage offered by the perineural catheters in providing postoperative pain relief. Pain assessments using standardized scales like the Numerical Rating Scale (NRS) will be conducted at regular intervals to measure pain scores & assess the duration of pain relief achieved with the use of perineural catheters.
研究者
Dr Dilfa Sharon
Christian Medical College, Vellore
