Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

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

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.

Study Overview

• Status: Terminated
• Conditions: Total Hip Replacement
• Intervention / Treatment: Procedure: Ropivacaine; Procedure: Bupivacaine

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Silkeborg, Denmark, 8600
    • Center for Planlagt Kirurgi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lumbosacral plexus blockade; Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural	Procedure: Ropivacaine; Lumbosacral plexus blockade with ropivacaine.
ACTIVE_COMPARATOR: Continuous spinal anesthesia; Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal	Procedure: Bupivacaine; Regional anesthesia with bupivacaine titrated to the lowest effective dose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Regionshospitalet Silkeborg
• Investigators: Principal Investigator: Niels D Nielsen, MD, Aarhus University, Dept. of Clinical Medicine; Study Director: Thomas F Bendtsen, MD, PhD, Aarhus University Hospital, Dept. of Anesthesiology

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): January 25, 2017
• Study Completion (ACTUAL): January 25, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (ESTIMATE): September 9, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Hemodynamics; Continuous spinal anesthesia; Lumbosacral plexus blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: HIP/FUSION#1; 2015-003498-13 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be made available through Danish Data Archive.