Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change of cardiac output
研究概览
简要总结
The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia.
详细描述
Patients for total hip replacement will be randomized for surgical anesthesia with either lumbosacral plexus blockade or continuous spinal anesthesia. All patients will receive central venous, arterial and spinal catheters. Hemodynamics will be monitored with transpulmonary thermodilution and pulse contour analysis. Perineural injection of study medicine around the lumbar and sacral plexus will be performed guided by ultrasound and nerve stimulation. Study medicine will be injected in divided doses in the spinal catheter. Treatment will be blinded using double-dummy technique. After the first intrathecal dose of study medicine, the hemodynamic response will be monitored for 60 minutes. Patients will then be transferred to the operating room, where total hip replacement will be performed in lumbosacral plexus blockade or spinal anesthesia according to randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for total hip replacement at Aarhus University Hospital
- •Age >= 50 years
- •American Society of Anesthesiologists physical status classification score I-III
- •Informed consent
排除标准
- •Lack of ability to cooperate
- •Lack of ability to speak Danish
- •Chronic pain, that demands opioid treatment. Not inkl. hip pain.
- •Previous venous thromboembolic event
- •Previous major back surgery
- •Severe cardiopulmonary disease (NYHA class 4)
- •Severe untreated hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 110 mm Hg)
- •Obesity (BMI > 35 kg/m^2)
- •Pregnancy
- •Allergy towards the used local analgetics
- •Current treatment with amiodarone or verapamil
研究组 & 干预措施
Continuous spinal anesthesia
Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal
干预措施: Bupivacaine (Procedure)
Lumbosacral plexus blockade
Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural
干预措施: Ropivacaine (Procedure)
结局指标
主要结局
Change of cardiac output
时间窗: Up to 1 hour
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
次要结局
- Cumulated peroperative opioid dose(Up to 2 hours)
- Cumulated postoperative opioid dose(Up to 24 hours)
- Surgeons self reported satisfaction with anesthesia(Up to 2 hours)
- Maximum plasma concentration of ropivacaine(80 minutes)
- Change of systemic vascular resistance(Up to 1 hour)
- Change of mean arterial pressure(Up to 1 hour)
- Success rate of nerve blocks(1 day)
- Change of cardiac stroke volume(Up to 1 hour)
- Change of plasma concentration of lactate(60 minutes)
- Cumulated peroperative propofol dose(Up to 2 hours)
- Time for performance of nerve blocks(At time of nerve block performance)
- Time from end of operation to first opioid dose(Up to 24 hours)
- Patients worst pain during surgery(Up to 2 hours)
- Change of central venous oxygen saturation(Up to 1 hour)