Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- University of Aarhus
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Change of cardiac output
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change of cardiac output
Time Frame: Up to 1 hour
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Secondary Outcomes
- Cumulated peroperative opioid dose(Up to 2 hours)
- Cumulated postoperative opioid dose(Up to 24 hours)
- Surgeons self reported satisfaction with anesthesia(Up to 2 hours)
- Maximum plasma concentration of ropivacaine(80 minutes)
- Change of systemic vascular resistance(Up to 1 hour)
- Change of mean arterial pressure(Up to 1 hour)
- Success rate of nerve blocks(1 day)
- Change of cardiac stroke volume(Up to 1 hour)
- Change of plasma concentration of lactate(60 minutes)
- Cumulated peroperative propofol dose(Up to 2 hours)
- Time for performance of nerve blocks(At time of nerve block performance)
- Time from end of operation to first opioid dose(Up to 24 hours)
- Patients worst pain during surgery(Up to 2 hours)
- Change of central venous oxygen saturation(Up to 1 hour)