A Phase 4 interventional study of Bupivacaine Spinal 0,5% Heavy - bolus and Bupivacaine Spinal 0,5% Heavy - titration in Anesthesia, Spinal and Hip Fractures, sponsored by Centre of Postgraduate Medical Education. Not yet recruiting at 2 sites in Poland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Centre of Postgraduate Medical Education · Phase 4, Interventional, and Treatment
This research project aims to identify a safer method of spinal anaesthesia for elderly patients undergoing surgical stabilisation of proximal femoral fractures.
The study's primary objective is to compare two spinal anaesthesia techniques: the continuous method (investigational), which allows titration of local anaesthetic doses through a catheter placed in the subarachnoid space, and the conventional single-shot bolus injection.
The main hypothesis is that the continuous catheter technique reduces the incidence of intraoperative hypotension and related complications, such as delirium, acute kidney injury, and cardiovascular events.
Beyond haemodynamic stability-assessed through advanced continuous monitoring of cardiac output and vascular resistance-the study will evaluate early and late complications, as well as quality of life up to 24 months post-surgery.
The project is a prospective, randomised, multicentre clinical trial including at least 216 patients over 50 years of age, randomly assigned to one of the two groups.
Proximal femoral fractures are a major and growing global health issue, particularly among geriatric patients with multiple comorbidities. The conventional single-shot spinal anaesthesia, though widely used, carries a high risk of hypotension, potentially leading to delirium, acute kidney injury, stroke, and cardiac events. These complications worsen prognosis, decrease quality of life, and increase mortality.
Most existing studies are over two decades old, based on small cohorts and outdated anaesthetic protocols, and lack long-term follow-up data (>30 days) on neurological outcomes, functional recovery, quality of life, and mortality. Moreover, no modern trials have provided direct, comprehensive comparisons between single-shot and continuous spinal anaesthesia.
This project therefore seeks to fill this critical evidence gap through a robust randomised clinical trial. Using precise, continuous measurements of arterial pressure, vascular resistance, and cardiac output, alongside long-term assessments of neurological outcomes, quality of life, and survival, it aims to determine whether continuous spinal anaesthesia offers superior safety and should become the new standard of care for this vulnerable population.
Study Flow Diagram.
Measured Variables, Measurement Scales, and Tools:
Anesthesia Method (determined by group randomization):
Intraoperative Monitoring of Vital Signs:
Advanced Monitoring: Continuous invasive blood pressure (IBP); uncalibrated cardiac output (CO) measurement-calibrated with stroke volume (SV) calculated by echocardiography (LVOT x VTI*); and continuous measurement of stroke volume variation (SVV), pulse pressure variation (PPV), and systemic vascular resistance (SVR) throughout the intraoperative period.
Monitoring in the Post-Anesthesia Care Unit (PACU):
Monitoring on the Orthopedic Ward:
a. At hospital discharge: An SF-36 assessment and a neurological assessment covering all endpoints specified in in the point 7 .
Complications associated with spinal anesthesia:
Exclusion Criteria:
Bolus dose of Bupivacaine Spinal 0,5% Heavy
Drug: Bupivacaine Spinal 0,5% Heavy - bolus
Dose titration of Bupivacaine Spinal 0,5% Heavy
Drug: Bupivacaine Spinal 0,5% Heavy - titration
Group 1 (Control Group) will receive single-shot spinal anesthesia with a bolus of 0.5% hyperbaric bupivacaine, with the dose adjusted according to the patient's weight and height to achieve a sensory block up to the T12 dermatome. The operating table will be kept in a neutral position.
Also known as: Single bolus
Group 2 (Interventional Group) will receive continuous spinal anesthesia administered via a dedicated intrathecal catheter. An initial induction dose of 1 ml of 0.5% hyperbaric bupivacaine will be administered, followed by titrated boluses of 0.5 ml every 15 minutes until a sensory block to the T12 dermatome is achieved. Once the desired block height is established, the anesthetic level will be maintained by administering titrated doses of 0.5-1 ml approximately every hour. The operating table will be kept in a neutral position.
Also known as: Rose titration
Mild hypotension
A comparison of frequency and duration of mild hypotensive episodes, defined as a 20% decrease in systolic arterial pressure (SAP) from the baseline value, between spinal anesthesia administered via catheter-based titration dosing (the investigational method) and single-shot administration (the conventional method)
Time frame: periprocedural
Severe hypotension
A comparison of frequency and duration of severe hypotension episodes, defined as a decrease in systolic arterial pressure (SAP) of 30% from the baseline value
Time frame: periprocedural
Hypotension associated with organ complications
Comparison of the incidence and duration of hypotensive episodes associated with organ complications, defined as a 50% decrease in mean arterial pressure (MAP) from the baseline value
Time frame: periprocedural
Advanced hemodynamic measurements
A comparison of the incidence and duration of decrease or increase in the following hemodynamic parameters from their baseline values: cardiac index, CI \[ l/min/m²\] , stroke volume index, SVI \[ml/m²\], stroke volume variation index, SVV \[%\] , pulse pressure variation, PPV \[ %\], and systemic vascular resistance index, SVRI \[ dyn·s·cm-⁵/m²\]. The hemodynamic parameters will be indexed for body surface area
Time frame: periprocedural
Bradycardia
Comparison of the incidence and duration of relative and absolute bradycardia, defined respectively as a heart rate (HR) below 60 and 40 beats per minute
Time frame: periprocedural
Hypotension-related complications
Comparison of the risk of hypotension-related complications between the study groups: 1. Delirium 2. Acute kidney injury (AKI)
Time frame: through hospitalisation completion, an average of 1 week
Length of stay
Comparison of the length of stay in the Post-Anesthesia Care Unit (PACU) and Intensive Care Unit (ICU), as well as the total hospital length of stay, between the study groups
Time frame: through hospitalisation completion, an average of 1 week
Mortality
Comparison of the risk of mortality at 1, 3, 6, 12, and 24 months between the study groups
Time frame: 0, 1mth, 3mth, 6mth, 12mth, 24mth
Complications associated with spinal anesthesia:
Comparison of the risk of complications associated with spinal anesthesia: 1. Postoperative nausea and vomiting (PONV) 2. Decrease in body temperature / Hypothermia 3. Total spinal anesthesia 4. Cardiac arrest 5. Bladder dysfunction 6. Back pain 7. Transient neurological symptoms (TNS) 8. Post-dural puncture headache (PDPH) 9. Headache other than PDPH 10. Peripheral nerve dysfunction 11. Cauda equina syndrome 12. Spinal hematoma or hygroma 13. Intracranial hypotension syndrome 14. Central nervous system infection 15. Other
Time frame: From admission to the hospital to the end of the 2-year follow-up period
Cardiovascular events
A comparison of the risk of cardiovascular events (ischemic stroke, acute coronary syndrome) during hospitalization between the study groups
Time frame: through hospitalisation completion, an average of 1 week
Other complications associated with the studied types of anesthesia
Comparison of the risk of other complications associated with the studied types of anesthesia
Time frame: 0 month, 1 month, 3 month, 6 month, 12 month, 24 month
Bromage motor blockade score
Comparison of the efficacy of both anesthetic techniques, as measured by the degree of motor blockade using the Bromage scale. Intensity of motor block, Modified Bromage score (Breen TW 1993) 1. Complete block (unable to move feet or knees) 2. Almost complete block (able to move feet only) 3. Partial block (just able to move knees) 4. Detectable weakness of hip flexion while supine (full flexion of knees) 5. No detectable weakness of hip flexion while supine 6. Able to perform partial knee bend
Time frame: periprocedural
Minimal clinically important difference
Assessment of the minimal clinically important difference (MCID) for patient-reported outcome measures (PROMs) to determine the value and extent of clinical improvement and the associated level of patient satisfaction
Time frame: 0 month, 1 month, 3 month, 6 month, 12 month, 24 month
Plan to share: No
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Centre of Postgraduate Medical Education