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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
8
Lumbosacral plexus blockade with ropivacaine.
Regional anesthesia with bupivacaine titrated to the lowest effective dose
Center for Planlagt Kirurgi
Silkeborg, Denmark
Change of cardiac output
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Time frame: Up to 1 hour
Time for performance of nerve blocks
Time range (in minutes) from first insertion to last withdrawal of nerve block needle.
Time frame: At time of nerve block performance
Success rate of nerve blocks
Time frame: 1 day
Change of cardiac stroke volume
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Time frame: Up to 1 hour
Change of systemic vascular resistance
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Time frame: Up to 1 hour
Change of mean arterial pressure
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Time frame: Up to 1 hour
Change of central venous oxygen saturation
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Time frame: Up to 1 hour
Maximum plasma concentration of ropivacaine
Arterial blood sampling at 20, 40, 60 and 80 minutes after 1st dose of intrathecal study medicine.
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Time frame: 80 minutes
Change of plasma concentration of lactate
Arterial blood sampling at 0, 30 and 60 minutes after 1st dose of intrathecal study medicine.
Time frame: 60 minutes
Cumulated peroperative propofol dose
Time frame: Up to 2 hours
Cumulated peroperative opioid dose
Time frame: Up to 2 hours
Cumulated postoperative opioid dose
Time frame: Up to 24 hours
Time from end of operation to first opioid dose
Time frame: Up to 24 hours
Surgeons self reported satisfaction with anesthesia
Numeric rating scale: 0-10
Time frame: Up to 2 hours
Patients worst pain during surgery
Numeric rating scale: 0-10
Time frame: Up to 2 hours