Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

University of Aarhus

Status and phase: Terminated; Phase 4

Conditions: Total Hip Replacement

Treatments: Procedure: Ropivacaine; Procedure: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02544269

HIP/FUSION#1

2015-003498-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups

Lumbosacral plexus blockade

Experimental group

Description:

Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural

Treatment:

Procedure: Ropivacaine

Continuous spinal anesthesia

Active Comparator group

Description:

Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal

Treatment:

Procedure: Bupivacaine