Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

Total Hip Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02544269
• Other study ID #: HIP/FUSION#1
• Secondary ID: 2015-003498-13
• Status: Terminated
• Phase: Phase 4
• First received: September 1, 2015
• Last updated: May 2, 2017
• Start date: June 1, 2016
• Est. completion date: January 25, 2017

Study information

• Verified date: March 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Procedure:
• Ropivacaine
Lumbosacral plexus blockade with ropivacaine.
• Bupivacaine
Regional anesthesia with bupivacaine titrated to the lowest effective dose

Locations

Country	Name	City	State
Denmark	Center for Planlagt Kirurgi	Silkeborg

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Regionshospitalet Silkeborg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Success rate of nerve blocks		1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maximum plasma concentration of ropivacaine	Arterial blood sampling at 20, 40, 60 and 80 minutes after 1st dose of intrathecal study medicine.	80 minutes
Secondary	Change of plasma concentration of lactate	Arterial blood sampling at 0, 30 and 60 minutes after 1st dose of intrathecal study medicine.	60 minutes
Secondary	Cumulated peroperative propofol dose		Up to 2 hours
Secondary	Cumulated peroperative opioid dose		Up to 2 hours
Secondary	Cumulated postoperative opioid dose		Up to 24 hours
Secondary	Time from end of operation to first opioid dose		Up to 24 hours
Secondary	Surgeons self reported satisfaction with anesthesia	Numeric rating scale: 0-10	Up to 2 hours
Secondary	Patients worst pain during surgery	Numeric rating scale: 0-10	Up to 2 hours