Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT02544269
Status:
TERMINATED
Last Update Posted:
2017-05-05
First Post:
2015-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
After pilot study no difference in the primary end point was found between the two primary. Non-inferiority trial not deemed feasible.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-003498-13 | EUDRACT_NUMBER | None | View |