Clinical trial NCT02544269: Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia
Official title: Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Total Hip Replacement
Keywords: Lumbosacral plexus blockade
Continuous spinal anesthesia
Hemodynamics
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Silkeborg
First posted: 2015-09-09
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients for total hip replacement at Aarhus University Hospital
* Age \>= 50 years
* American Society of Anesthesiologists physical status classification score I-III
* Informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of cardiac output
timeFrame: Up to 1 hour
Secondary outcomes:
measure: Time for performance of nerve blocks
timeFrame: At time of nerve block performance
measure: Success rate of nerve blocks
timeFrame: 1 day
measure: Change of cardiac stroke volume
timeFrame: Up to 1 hour
measure: Change of systemic vascular resistance
timeFrame: Up to 1 hour
measure: Change of mean arterial pressure
timeFrame: Up to 1 hour
measure: Change of central venous oxygen saturation
timeFrame: Up to 1 hour
measure: Maximum plasma concentration of ropivacaine
timeFrame: 80 minutes
measure: Change of plasma concentration of lactate
timeFrame: 60 minutes
measure: Cumulated peroperative propofol dose
timeFrame: Up to 2 hours
measure: Cumulated peroperative opioid dose
timeFrame: Up to 2 hours
measure: Cumulated postoperative opioid dose
timeFrame: Up to 24 hours
measure: Time from end of operation to first opioid dose
timeFrame: Up to 24 hours
measure: Surgeons self reported satisfaction with anesthesia
timeFrame: Up to 2 hours
measure: Patients worst pain during surgery
timeFrame: Up to 2 hours
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Center for Planlagt Kirurgi
Study officials:
affiliation: Aarhus University, Dept. of Clinical Medicine
name: Niels D Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital, Dept. of Anesthesiology
name: Thomas F Bendtsen, MD, PhD
role: STUDY_DIRECTOR
References: