Femoral Artery Block for Reduction of Tourniquet Induced Hypertension: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Mean arterial pressure (MAP) 30 minutes after tourniquet inflation
研究概览
简要总结
A randomised controlled trial to assess the impact of femoral artery block on the incidence of tourniquet hypertension in patients receiving cruciate ligament surgery with > 30 minutes of tourniquet under combined anaesthesia (balanced general anaesthesia and femoral nerve blocks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I to III
- •Receiving cruciate ligament surgery with > 30 minutes of tourniquet
- •Combined anesthesia (balanced general anesthesia and femoral nerve block)
排除标准
- •Nerve block contraindications (block site infection, allergic to local anesthetic)
- •Tourniquet contraindications (peripheral vascular disease or neuropathy, previous arterial bypass graft)
- •Tourniquet inflation time < 30 min
- •Patient refusal
- •Pregnant patients
- •Patients with a active psychiatric disease.
研究组 & 干预措施
Femoral artery block
An experienced Anesthesiologist will perform the femoral blocks, under ultrasound guidance with a linear probe and a 50mm (millimeters) or 80mm needle. No nerve stimulator will be used during the block. In both groups, femoral nerve block at the nerve sheath will be performed with 20mL (milliliters) 0.5% ropivacaine. In the interventional group, additionally to the previous block, the needle will be retracted and advanced to the antero-medial side of the femoral artery where 10mL 0.5% ropivacaine will be injected after negative aspiration.
干预措施: Femoral artery block (Other)
No intervention
结局指标
主要结局
Mean arterial pressure (MAP) 30 minutes after tourniquet inflation
时间窗: 30 minutes after tourniquet inflation
MAP at 30 minutes after tourniquet inflation
Systolic blood pressure 60 minutes after tourniquet inflation
时间窗: 60 minutes after tourniquet inflation
SBP at 60 minutes after tourniquet inflation
Systolic blood pressure 45 minutes after tourniquet inflation
时间窗: 45 minutes after tourniquet inflation
SBP at 45 minutes after tourniquet inflation
Systolic blood pressure 75 minutes after tourniquet inflation
时间窗: 75 minutes after tourniquet inflation
SBP at 75 minutes after tourniquet inflation
Mean arterial pressure 45 minutes after tourniquet inflation
时间窗: 45 minutes after tourniquet inflation
MAP at 45 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 45 minutes after tourniquet inflation
时间窗: 45 minutes after tourniquet inflation
Variation of SBP compared to baseline at 45 minutes after tourniquet inflation
Systolic blood pressure 115 minutes after tourniquet inflation
时间窗: 115 minutes after tourniquet inflation
SBP at 115 minutes after tourniquet inflation
Systolic blood pressure 130 minutes after tourniquet inflation
时间窗: 130 minutes after tourniquet inflation
SBP at 130 minutes after tourniquet inflation
Mean arterial pressure 130 minutes after tourniquet inflation
时间窗: 130 minutes after tourniquet inflation
MAP at 130 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 60 minutes after tourniquet inflation
时间窗: 60 minutes after tourniquet inflation
Variation of SBP compared to baseline at 60 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 30 minutes after tourniquet inflation
时间窗: 30 minutes after tourniquet inflation
Variation of MAP compared to baseline at 30 minutes after tourniquet inflation
Systolic blood pressure 30 minutes after tourniquet inflation
时间窗: 30 minutes after tourniquet inflation
SBP at 30 minutes after tourniquet inflation
Mean arterial pressure 75 minutes after tourniquet inflation
时间窗: 75 minutes after tourniquet inflation
MAP at 75 minutes after tourniquet inflation
Mean arterial pressure 90 minutes after tourniquet inflation
时间窗: 90 minutes after tourniquet inflation
MAP at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 60 minutes after tourniquet inflation
时间窗: 60 minutes after tourniquet inflation
Variation of MAP compared to baseline at 60 minutes after tourniquet inflation
Incidence of Tourniquet Hypertension (TH)
时间窗: Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia)
Defined as Systolic Blood Pressure (SBP) increased \>30% after 30 minutes of tourniquet
Systolic blood pressure 90 minutes after tourniquet inflation
时间窗: 90 minutes after tourniquet inflation
SBP at 90 minutes after tourniquet inflation
Mean arterial pressure 60 minutes after tourniquet inflation
时间窗: 60 minutes after tourniquet inflation
MAP at 60 minutes after tourniquet inflation
Mean arterial pressure 115 minutes after tourniquet inflation
时间窗: 115 minutes after tourniquet inflation
MAP at 115 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 75 minutes after tourniquet inflation
时间窗: 75 minutes after tourniquet inflation
Variation of SBP compared to baseline at 75 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 115 minutes after tourniquet inflation
时间窗: 115 minutes after tourniquet inflation
Variation of SBP compared to baseline at 115 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 130 minutes after tourniquet inflation
时间窗: 130 minutes after tourniquet inflation
Variation of SBP compared to baseline at 130 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 30 minutes after tourniquet inflation
时间窗: 30 minutes after tourniquet inflation
Variation of SBP compared to baseline at 30 minutes after tourniquet inflation
Systolic blood pressure variation from baseline at 90 minutes after tourniquet inflation
时间窗: 90 minutes after tourniquet inflation
Variation of SBP compared to baseline at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 45 minutes after tourniquet inflation
时间窗: 45 minutes after tourniquet inflation
Variation of MAP compared to baseline at 45 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 75 minutes after tourniquet inflation
时间窗: 75 minutes after tourniquet inflation
Variation of MAP compared to baseline at 75 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 90 minutes after tourniquet inflation
时间窗: 90 minutes after tourniquet inflation
Variation of MAP compared to baseline at 90 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 115 minutes after tourniquet inflation
时间窗: 115 minutes after tourniquet inflation
Variation of MAP compared to baseline at 115 minutes after tourniquet inflation
Mean arterial pressure variation from baseline at 130 minutes after tourniquet inflation
时间窗: 130 minutes after tourniquet inflation
Variation of MAP compared to baseline at 130 minutes after tourniquet inflation
次要结局
- Isosorbide dinitrate administered for TH(Thought intra-operative time (after induction of anesthesia and until emergence from anesthesia) ))
- Numerical verbal pain scores(Up to 2 hours after emergence from anesthesia)
- Patient post-operative satisfaction(Up to 2 hours after emergence from anesthesia)
研究者
Vasyl Katerenchuk
Anaesthesiology Resident
Hospital da Luz, Portugal