Comparison of the Effect of Subarachnoid Block and Femoropopliteal Block to Limb Perfusion in Patients with Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Measurement of Tissue Oxygen Saturation (StO2)
研究概览
简要总结
This pilot study investigates the effects of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries. Using Near-Infrared Spectroscopy (NIRS), the study compares changes in StO2 post-block. Although no significant differences were found between the two block types at most time points, subarachnoid blocks generally led to higher StO2 increases compared to femoropopliteal blocks, with significant differences observed at 5 and 15 minutes post-block.
详细描述
This pilot study explored the impact of femoropopliteal and subarachnoid nerve blocks on tissue oxygen saturation (StO2) in patients with Peripheral Arterial Disease (PAD) during lower limb surgeries, using Near-Infrared Spectroscopy (NIRS) for non-invasive monitoring. The study compared StO2 changes at baseline, 5, 15, and 30 minutes post-block in two groups: those receiving femoropopliteal blocks and those receiving subarachnoid blocks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single Blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old who are scheduled to undergo lower limb debridement surgery.
- •Diagnosis of Peripheral Arterial Disease (PAD).
- •Lesion located below the knee.
排除标准
- •Consuming opioids before hospital admission.
- •Having allergies to the medications used in the study.
- •Presence of infection at the injection site.
研究组 & 干预措施
Femoropopliteal block (Group F)
Ultrasonography was performed using the Mindray DP-10 system with a linear transducer positioned at the inguinal fold to identify and visualize the femoral nerve, 10 ml mixture of local anesthetics ( Marcaine® [bupivacaine HCl] 0,5% and Xylocaine® [Lidocaine HCL] 2% = 2:1) were injected in-plane around the femoral nerve. For popliteal sciatic nerve blocks, linear transducer was placed transversally on the distal thigh to visualize Sciatic nerve just before branching, followed by the injection of 20 ml of the same mixture of local anesthetics through a 50 mm block needle in-plane
干预措施: Mixture of local anesthetics (Drug)
Subarachnoid block (Group S)
Patients may assume either a sitting or lateral decubitus position, and subsequent to aseptic procedures, a G27 spinal needle will be introduced into the L3-4 interspinous space until clear cerebrospinal fluid visualization, followed by the injection of 2-2.5 ml of 0.5% hyperbaric Bupivacaine
干预措施: 0.5% hyperbaric bupivacaine (Drug)
结局指标
主要结局
Measurement of Tissue Oxygen Saturation (StO2)
时间窗: TI (Baseline): 10 minutes before the intervention; T2: 5 minutes after the intervention; T3: 15 minutes after the intervention; T4: 30 minutes after the intervention
The primary outcome of this study is the percentage increase in tissue oxygen saturation (StO2) following the administration of femoropopliteal nerve blocks and spinal anesthesia. StO2 will be measured at two locations below the knee (Points A and B) at different heights. Measurements will be taken at four time points: 10 minutes before the intervention (TI), and 5, 15, and 30 minutes after the intervention (T2, T3, T4). The goal is to assess and compare the changes in StO2 induced by each type of anesthesia.
次要结局
未报告次要终点
研究者
Aida Rosita Tantri
Principal Investigator
Indonesia University