Clinical Trials Directory

Trials / Terminated

TerminatedNCT02544269

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

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
8 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURERopivacaineLumbosacral plexus blockade with ropivacaine.
PROCEDUREBupivacaineRegional anesthesia with bupivacaine titrated to the lowest effective dose

Timeline

Start date
2016-06-01
Primary completion
2017-01-25
Completion
2017-01-25
First posted
2015-09-09
Last updated
2017-05-05

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02544269. Inclusion in this directory is not an endorsement.