Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

NCT ID: NCT02544269

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-01-25

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.

Conditions

Total Hip Replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Lumbosacral plexus blockade

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

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: PROCEDURE

Lumbosacral plexus blockade with ropivacaine.

Continuous spinal anesthesia

Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: PROCEDURE

Regional anesthesia with bupivacaine titrated to the lowest effective dose

Interventions

Ropivacaine

Lumbosacral plexus blockade with ropivacaine.

Intervention Type: PROCEDURE

Bupivacaine

Regional anesthesia with bupivacaine titrated to the lowest effective dose

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Regionshospitalet Silkeborg

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels D Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Dept. of Clinical Medicine

Thomas F Bendtsen, MD, PhD

Role: STUDY_DIRECTOR

Aarhus University Hospital, Dept. of Anesthesiology

Locations

Center for Planlagt Kirurgi

Silkeborg, , Denmark

Countries

Denmark

Other Identifiers

2015-003498-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HIP/FUSION#1

Identifier Type: -

Identifier Source: org_study_id