Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia

Conditions
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Total Hip Replacement

Intervention / Treatment
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* Procedure: Ropivacaine
* Procedure: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbosacral plexus blockade<br>Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural | Procedure: Ropivacaine<br>* Lumbosacral plexus blockade with ropivacaine.<br>|
| Active Comparator: Continuous spinal anesthesia<br>Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal | Procedure: Bupivacaine<br>* Regional anesthesia with bupivacaine titrated to the lowest effective dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cardiac output | Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine. | Up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for performance of nerve blocks | Time range (in minutes) from first insertion to last withdrawal of nerve block needle. | At time of nerve block performance | 
| Success rate of nerve blocks |  | 1 day | 
| Change of cardiac stroke volume | Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine. | 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. | 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. | 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. | 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. | 80 minutes | 
| Change of plasma concentration of lactate | Arterial blood sampling at 0, 30 and 60 minutes after 1st dose of intrathecal study medicine. | 60 minutes | 
| Cumulated peroperative propofol dose |  | Up to 2 hours | 
| Cumulated peroperative opioid dose |  | Up to 2 hours | 
| Cumulated postoperative opioid dose |  | Up to 24 hours | 
| Time from end of operation to first opioid dose |  | Up to 24 hours | 
| Surgeons self reported satisfaction with anesthesia | Numeric rating scale: 0-10 | Up to 2 hours | 
| Patients worst pain during surgery | Numeric rating scale: 0-10 | Up to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbosacral plexus blockade, Continuous spinal anesthesia, Hemodynamics