Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

Phase 4

Terminated

• Conditions: Total Hip Replacement
• Interventions: Procedure: Ropivacaine; Procedure: Bupivacaine

• Registration Number: NCT02544269
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Status Verified: 2016-03
• Study Start: 2016-06-01
• Primary Completion: 2017-01-25
• Study Completion: 2017-01-25
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbosacral plexus blockade	Ropivacaine	Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural
Continuous spinal anesthesia	Bupivacaine	Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal

Primary Outcome Measures

Name	Time	Method
Change of cardiac output	Up to 1 hour	Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.

Secondary Outcome Measures

Name	Time	Method
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	Numeric rating scale: 0-10
Maximum plasma concentration of ropivacaine	80 minutes	Arterial blood sampling at 20, 40, 60 and 80 minutes after 1st dose of intrathecal study medicine.
Change of systemic vascular resistance	Up to 1 hour	Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Change of mean arterial pressure	Up to 1 hour	Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Success rate of nerve blocks	1 day
Change of cardiac stroke volume	Up to 1 hour	Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Change of plasma concentration of lactate	60 minutes	Arterial blood sampling at 0, 30 and 60 minutes after 1st dose of intrathecal study medicine.
Cumulated peroperative propofol dose	Up to 2 hours
Time for performance of nerve blocks	At time of nerve block performance	Time range (in minutes) from first insertion to last withdrawal of nerve block needle.
Time from end of operation to first opioid dose	Up to 24 hours
Patients worst pain during surgery	Up to 2 hours	Numeric rating scale: 0-10
Change of central venous oxygen saturation	Up to 1 hour	Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.

Trial Locations

Locations (1)

Center for Planlagt Kirurgi; 🇩🇰 Silkeborg, Denmark