Anesthesia, SpinalPhase 4CHIPSNCT07358299

Haemodynamic Effects and Complications of Continuous Versus Single-shot Spinal Anaesthesia for HIP Fracture Surgery

A Phase 4 study testing Bupivacaine Spinal 0,5% Heavy - bolus and Bupivacaine Spinal 0,5% Heavy - titration in people with Anesthesia, Spinal and Hip Fractures, run by Centre of Postgraduate Medical Education at 2 sites in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Anesthesia, Spinal, Hip Fractures
What is being tested?: Bupivacaine Spinal 0,5% Heavy - bolus and Bupivacaine Spinal 0,5% Heavy - titration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 2 sitesPoland
Study dates: 15 Jan 2026to 1 Nov 2029
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 50 years, regardless of gender
Diagnosis of a proximal femur fracture
Orthopedic qualification for open reduction and internal fixation of the fracture
Informed consent for the surgical procedure
Informed consent for regional anesthesia, i.e., a central neuraxial block (spinal anesthesia)
Informed consent to participate in the study

Who cannot join

Age < 50 years, regardless of gender
Refusal to consent to surgical treatment
Refusal to consent to regional anesthesia
Refusal to consent to participate in the study
Inability to provide informed consent
Allergy to local anesthetic agents

Show all 12Show fewer

Severe congenital or acquired coagulation disorders
Failure to meet the recommended time interval between the last dose of an anticoagulant and central neuraxial blockade, according to the 2022 European Journal of Anaesthesiology (EJA) guidelines
Infection at the block site or a systemic infection (i.e., sepsis, septic shock)
Patients with multiple organ dysfunction syndrome requiring hospitalization in the Intensive Care Unit for stabilization of vital functions
Clinical signs of increased intracranial pressure or suspicion of an intracranial mass on imaging studies
Other contraindications to spinal anesthesia as judged by the qualifying physician

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Magdalena Fleming, MD contact

00 48 509 995 408

m.fleming@spskgruca.pl

Rafał Kamiński, MD, PhD contact

0048 502 775 345

rkaminski@spskgruca.pl

Poland2 sites

Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital, Konarskiego 13 street
Otwock, 05-400
Rafał Kamiński, MD, PhD, 00 48 22 788 56 75, kl.chir.ur@spskgruca.pl
Piotr Nowakowski, MD, PhD, 00 48 22 779 40 31, x@spskgruca.pl
National Medical Institute of the Ministry of the Interior and Administration, Wołoska 137 street
Warsaw, 02507
Konstanty Szułdrzyński, MD, PhD, 00 48 47 722 10 20, dyrekcja@cskmswia.gov.pl
Miłosz Jankowski, MD, PhD, 00 48 47 722 14 50, anestezjologia@pimmswia.gov.pl

Other trials in Poland

About this study

Official title: A Comparison of Haemodynamic Effects, as Assessed by Cardiac Output Monitoring, and Complications of Continuous Versus Single-Shot Spinal Anaesthesia for Hip-Fracture Surgery in Patients Over 50 Years of Age

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.

Read the detailed description

Study Flow Diagram.

Measured Variables, Measurement Scales, and Tools:

Orthopedic and Anesthesiological Qualification: Conducted according to the standard of care and existing procedures at the participating hospital.
Baseline Assessment: Performed using the following scales: ASA, Apfel, GCS, RASS, NRS, Bromage, Aldrete, CAM-ICU, and SF-36.
Baseline Neurological Assessment: Covering all neurological endpoints specified in the point 7
Anesthesia Method (determined by group randomization):

Both groups: Ultrasound-guided femoral nerve block with 10 ml of 0.5% ropivacaine.
Group 1 (Interventional): Continuous spinal anesthesia with titrated doses of 0.5% hyperbaric bupivacaine via an intrathecal catheter. An initial 1 ml induction dose will be administered, followed by 0.5 ml boluses every 15 minutes to achieve a sensory block to the T12 level. Once the block is established, the anesthetic level will be maintained with titrated doses of 0.5-1 ml approximately every hour. The operating table will be kept in a neutral position.
Group 2 (Control): 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 to the T12 level. The operating table will be kept in a neutral position.
Intraoperative Monitoring of Vital Signs:
Standard Monitoring: Continuous measurement of heart rate (HR) via ECG and arterial oxygen saturation (SpO2) via pulse oximetry, as well as non-invasive blood pressure (NIBP) measured at 3, 5, and 15-minute intervals.
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.

Calculated as the product of the left ventricular outflow tract (LVOT) area and the velocity time integral (VTI), measured in the parasternal long-axis and apical 5-chamber views, respectively.

Monitoring in the Post-Anesthesia Care Unit (PACU):
Continuation of standard vital signs monitoring (HR, BP, SpO2).
Continuation of advanced hemodynamic monitoring if hemodynamic instability requires a continuous vasopressor infusion; patients will be transferred to the ICU if stabilization is not achieved.
At discharge from PACU: Assessment using the GCS, RASS, NRS, Aldrete, CAM-ICU, and SF-36 scales, and a neurological assessment covering all endpoints specified in in the point 7 .
Monitoring on the Orthopedic Ward:
At hospital discharge: An SF-36 assessment and a neurological assessment covering all endpoints specified in in the point 7 .
Assessment of Other Complications: The incidence of other in-hospital complications will be assessed according to established diagnostic criteria if they are suspected to have occurred.
Follow-up: Conducted at 1, 3, 6, 12, and 24 months post-intervention. A telephone interview will be performed to complete the SF-36 scale and conduct a neurological assessment covering all endpoints specified in the point 7 .
Complications associated with spinal anesthesia:
Postoperative nausea and vomiting (PONV)
Hypothermia
Total spinal anesthesia
Cardiac arrest
Bladder dysfunction
Back pain
Transient neurological symptoms (TNS)
Post-dural puncture headache (PDPH)
Headache other than PDPH
Peripheral nerve palsy
Cauda equina syndrome
Spinal hematoma or hygroma
Intracranial hypotension syndrome
Central nervous system infection
Other

Conditions: Anesthesia, Spinal, Hip Fractures
Being tested: Bupivacaine Spinal 0,5% Heavy - bolus, Bupivacaine Spinal 0,5% Heavy - titration
Keywords: Continuous spinal anaesthesia, Late side effects of spinal anaesthesia, Haemodynamic stability, Follow-up care after proximal femoral fractures, Quality of life after proximal femoral fractures
Medical subject headings: Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine Spinal 0,5% Heavy - bolusDrug
Also called Single bolus
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.
Bupivacaine Spinal 0,5% Heavy - titrationDrug
Also called Rose titration
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.

Study groups in NCT07358299
Study group	Role	What they receive
Single-shot spinal anaesthesia	Experimental	Bolus dose of Bupivacaine Spinal 0,5% Heavy Receives: Drug: Bupivacaine Spinal 0,5% Heavy - bolus
Continuous spinal anaesthesia	Experimental	Dose titration of Bupivacaine Spinal 0,5% Heavy Receives: Drug: Bupivacaine Spinal 0,5% Heavy - titration

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: periprocedural

Secondary outcomes (12)

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
Measured: 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
Measured: 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
Measured: 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
Measured: periprocedural
Hypotension-related complications
Comparison of the risk of hypotension-related complications between the study groups:
1. Delirium
2. Acute kidney injury (AKI)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 month, 1 month, 3 month, 6 month, 12 month, 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20261 Nov 2029

First posted22 Jan 2026
Study start15 Jan 2026 (estimated)
Primary completion1 Nov 2027 (estimated)
Study completion1 Nov 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 216 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07358299
Sponsor's protocol ID: No. 65/2025 of 16 July 2025
Acronym: CHIPS
Status last verified: Jan 2026
First submitted: 10 Sep 2025
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Raichandani K, Agarwal S, Jain H, Bharwani N. Mortality profile after 2 years of hip fractures in elderly patients treated with early surgery. J Clin Orthop Trauma. 2021 Apr 15;18:1-5. doi: 10.1016/j.jcot.2021.04.009. eCollection 2021 Jul.
PubMed 33936949
Favarel-Garrigues JF, Sztark F, Petitjean ME, Thicoipe M, Lassie P, Dabadie P. Hemodynamic effects of spinal anesthesia in the elderly: single dose versus titration through a catheter. Anesth Analg. 1996 Feb;82(2):312-6. doi: 10.1097/00000539-199602000-00017.
PubMed 8561333
Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
PubMed 16632842
Koole C, Bleeser T, Hoogma DF, Coppens S, Teunkens A, Rex S. Haemodynamic effects of continuous spinal anaesthesia versus single-shot spinal anaesthesia or general anaesthesia for hip fracture surgery: a systematic review and meta-analysis. Br J Anaesth. 2024 May;132(5):1160-1162. doi: 10.1016/j.bja.2023.12.012. Epub 2024 Jan 18. No abstract available.
PubMed 38242801
Viderman D, Aubakirova M, Nabidollayeva F, Abdildin YG. The Analysis of Multiple Outcomes between General and Regional Anesthesia in Hip Fracture Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2023 Dec 5;12(24):7513. doi: 10.3390/jcm12247513.
PubMed 38137582
Uppalapati T, Thornton I. Anesthesia Management of Hip Fracture Surgery in Geriatric Patients: A Review. Cureus. 2024 Sep 25;16(9):e70188. doi: 10.7759/cureus.70188. eCollection 2024 Sep.
PubMed 39463540
Barbosa TA, Souza AMF, Leme FCO, Grassi LDV, Cintra FB, Lima RME, Gumieiro DN, Lima LHNE. [Perioperative complications and mortality in elderly patients following surgery for femoral fracture: prospective observational study]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):569-579. doi: 10.1016/j.bjan.2019.09.004. Epub 2019 Nov 11.
PubMed 31722793
Stachurski J, Sionek A. Epidemiology of femoral shaft fractures in Poland. Przegl Epidemiol. 2020;74(3):492-502. doi: 10.32394/pe.74.43.
PubMed 33576588
Wilk R, Skrzypek M, Kowalska M, Kusz D, Wielgorecki A, Horyniecki M, Sliwiak J, Piejczyk S, Pluskiewicz W. Standardized incidence and trend of osteoporotic hip fracture in Polish women and men: a nine year observation. Maturitas. 2014 Jan;77(1):59-63. doi: 10.1016/j.maturitas.2013.09.004. Epub 2013 Sep 14.
PubMed 24090926
Czerwinski E, Kanis JA, Trybulec B, Johansson H, Borowy P, Osieleniec J. The incidence and risk of hip fracture in Poland. Osteoporos Int. 2009 Aug;20(8):1363-7. doi: 10.1007/s00198-008-0787-8. Epub 2008 Nov 14.
PubMed 19009330
Lotan R, Moayad C, Sakhnini M, Rijini N, Goldstein AL, Hershkovich O. In-Hospital Proximal Femoral Fracture Mortality and Anesthesia: Do the First Postoperative 72 h Matter? J Clin Med. 2025 Mar 11;14(6):1885. doi: 10.3390/jcm14061885.
PubMed 40142693
Chatzopoulos ST, Zafeiris CP. Epidemiology of hip fractures in Europe: Geographic variability. Journal of Research & Practice on the Musculoskeletal System (JRPMS). 2023 Dec 1;7(4).

Interested in taking part?

Magdalena Fleming, MD

00 48 509 995 408

m.fleming@spskgruca.pl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
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All Anesthesia, Spinal trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Haemodynamic Effects, as Assessed by Cardiac Output Monitoring, and Complications of Continuous Versus Single-Shot Spinal Anaesthesia for Hip-Fracture Surgery in Patients Over 50 Years of Age
ClinicalTrials.gov ID: NCT07358299
Acronym / sponsor ID: CHIPS / No. 65/2025 of 16 July 2025
Conditions: Anesthesia, Spinal, Hip Fractures
Keywords: Continuous spinal anaesthesia, Late side effects of spinal anaesthesia, Haemodynamic stability, Follow-up care after proximal femoral fractures, Quality of life after proximal femoral fractures
Phase: Phase 4
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 216 participants (estimated)
Lead sponsor: Centre of Postgraduate Medical EducationUniversity, hospital or other
Collaborators: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Study start: 15 Jan 2026 (estimated)
Primary completion: 1 Nov 2027 (estimated)
Study completion: 1 Nov 2029 (estimated)
First posted: 22 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This research project aims to identify a safer method of spinal anaesthesia for elderly patients undergoing surgical stabilisation of proximal femoral fractures.

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.

Detailed description

Study Flow Diagram.

Measured Variables, Measurement Scales, and Tools:

Orthopedic and Anesthesiological Qualification: Conducted according to the standard of care and existing procedures at the participating hospital.
Baseline Assessment: Performed using the following scales: ASA, Apfel, GCS, RASS, NRS, Bromage, Aldrete, CAM-ICU, and SF-36.
Baseline Neurological Assessment: Covering all neurological endpoints specified in the point 7
Anesthesia Method (determined by group randomization):

Both groups: Ultrasound-guided femoral nerve block with 10 ml of 0.5% ropivacaine.
Group 1 (Interventional): Continuous spinal anesthesia with titrated doses of 0.5% hyperbaric bupivacaine via an intrathecal catheter. An initial 1 ml induction dose will be administered, followed by 0.5 ml boluses every 15 minutes to achieve a sensory block to the T12 level. Once the block is established, the anesthetic level will be maintained with titrated doses of 0.5-1 ml approximately every hour. The operating table will be kept in a neutral position.
Group 2 (Control): 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 to the T12 level. The operating table will be kept in a neutral position.
Intraoperative Monitoring of Vital Signs:
Standard Monitoring: Continuous measurement of heart rate (HR) via ECG and arterial oxygen saturation (SpO2) via pulse oximetry, as well as non-invasive blood pressure (NIBP) measured at 3, 5, and 15-minute intervals.
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.

Calculated as the product of the left ventricular outflow tract (LVOT) area and the velocity time integral (VTI), measured in the parasternal long-axis and apical 5-chamber views, respectively.

Monitoring in the Post-Anesthesia Care Unit (PACU):
Continuation of standard vital signs monitoring (HR, BP, SpO2).
Continuation of advanced hemodynamic monitoring if hemodynamic instability requires a continuous vasopressor infusion; patients will be transferred to the ICU if stabilization is not achieved.
At discharge from PACU: Assessment using the GCS, RASS, NRS, Aldrete, CAM-ICU, and SF-36 scales, and a neurological assessment covering all endpoints specified in in the point 7 .
Monitoring on the Orthopedic Ward:
At hospital discharge: An SF-36 assessment and a neurological assessment covering all endpoints specified in in the point 7 .
Assessment of Other Complications: The incidence of other in-hospital complications will be assessed according to established diagnostic criteria if they are suspected to have occurred.
Follow-up: Conducted at 1, 3, 6, 12, and 24 months post-intervention. A telephone interview will be performed to complete the SF-36 scale and conduct a neurological assessment covering all endpoints specified in the point 7 .
Complications associated with spinal anesthesia:
Postoperative nausea and vomiting (PONV)
Hypothermia
Total spinal anesthesia
Cardiac arrest
Bladder dysfunction
Back pain
Transient neurological symptoms (TNS)
Post-dural puncture headache (PDPH)
Headache other than PDPH
Peripheral nerve palsy
Cauda equina syndrome
Spinal hematoma or hygroma
Intracranial hypotension syndrome
Central nervous system infection
Other

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Single-shot spinal anaesthesia	Experimental	Drug: Bupivacaine Spinal 0,5% Heavy - bolusBolus dose of Bupivacaine Spinal 0,5% Heavy
Continuous spinal anaesthesia	Experimental	Drug: Bupivacaine Spinal 0,5% Heavy - titrationDose titration of Bupivacaine Spinal 0,5% Heavy

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age > 50 years, regardless of gender
Diagnosis of a proximal femur fracture
Orthopedic qualification for open reduction and internal fixation of the fracture
Informed consent for the surgical procedure
Informed consent for regional anesthesia, i.e., a central neuraxial block (spinal anesthesia)

Key exclusion criteria (12 listed)

Age < 50 years, regardless of gender
Refusal to consent to surgical treatment
Refusal to consent to regional anesthesia
Refusal to consent to participate in the study
Inability to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine Spinal 0,5% Heavy - bolusAlso: Single bolusGroup 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.	Drug	Single-shot spinal anaesthesia
Bupivacaine Spinal 0,5% Heavy - titrationAlso: Rose titrationGroup 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.	Drug	Continuous spinal anaesthesia

Primary outcome

Mild hypotension
Time frame: periprocedural
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)

12 secondary outcomes

Severe hypotension
Time frame: periprocedural
Hypotension associated with organ complications
Time frame: periprocedural
Advanced hemodynamic measurements
Time frame: periprocedural
Bradycardia
Time frame: periprocedural
Hypotension-related complications
Time frame: through hospitalisation completion, an average of 1 week
Length of stay
Time frame: through hospitalisation completion, an average of 1 week
Mortality
Time frame: 0, 1mth, 3mth, 6mth, 12mth, 24mth
Complications associated with spinal anesthesia:
Time frame: From admission to the hospital to the end of the 2-year follow-up period
Cardiovascular events
Time frame: through hospitalisation completion, an average of 1 week
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
Time frame: periprocedural
Minimal clinically important difference
Time frame: 0 month, 1 month, 3 month, 6 month, 12 month, 24 month

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Background: PubMed 33936949Raichandani K, Agarwal S, Jain H, Bharwani N. Mortality profile after 2 years of hip fractures in elderly patients treated with early surgery. J Clin Orthop Trauma. 2021 Apr 15;18:1-5. doi: 10.1016/j.jcot.2021.04.009. eCollection 2021 Jul.
Background: PubMed 8561333Favarel-Garrigues JF, Sztark F, Petitjean ME, Thicoipe M, Lassie P, Dabadie P. Hemodynamic effects of spinal anesthesia in the elderly: single dose versus titration through a catheter. Anesth Analg. 1996 Feb;82(2):312-6. doi: 10.1097/00000539-199602000-00017.
Background: PubMed 16632842Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
Background: PubMed 38242801Koole C, Bleeser T, Hoogma DF, Coppens S, Teunkens A, Rex S. Haemodynamic effects of continuous spinal anaesthesia versus single-shot spinal anaesthesia or general anaesthesia for hip fracture surgery: a systematic review and meta-analysis. Br J Anaesth. 2024 May;132(5):1160-1162. doi: 10.1016/j.bja.2023.12.012. Epub 2024 Jan 18. No abstract available.
Background: PubMed 38137582Viderman D, Aubakirova M, Nabidollayeva F, Abdildin YG. The Analysis of Multiple Outcomes between General and Regional Anesthesia in Hip Fracture Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2023 Dec 5;12(24):7513. doi: 10.3390/jcm12247513.
Background: PubMed 39463540Uppalapati T, Thornton I. Anesthesia Management of Hip Fracture Surgery in Geriatric Patients: A Review. Cureus. 2024 Sep 25;16(9):e70188. doi: 10.7759/cureus.70188. eCollection 2024 Sep.
Background: PubMed 31722793Barbosa TA, Souza AMF, Leme FCO, Grassi LDV, Cintra FB, Lima RME, Gumieiro DN, Lima LHNE. [Perioperative complications and mortality in elderly patients following surgery for femoral fracture: prospective observational study]. Braz J Anesthesiol. 2019 Nov-Dec;69(6):569-579. doi: 10.1016/j.bjan.2019.09.004. Epub 2019 Nov 11.
Background: PubMed 33576588Stachurski J, Sionek A. Epidemiology of femoral shaft fractures in Poland. Przegl Epidemiol. 2020;74(3):492-502. doi: 10.32394/pe.74.43.
Background: PubMed 24090926Wilk R, Skrzypek M, Kowalska M, Kusz D, Wielgorecki A, Horyniecki M, Sliwiak J, Piejczyk S, Pluskiewicz W. Standardized incidence and trend of osteoporotic hip fracture in Polish women and men: a nine year observation. Maturitas. 2014 Jan;77(1):59-63. doi: 10.1016/j.maturitas.2013.09.004. Epub 2013 Sep 14.
Background: PubMed 19009330Czerwinski E, Kanis JA, Trybulec B, Johansson H, Borowy P, Osieleniec J. The incidence and risk of hip fracture in Poland. Osteoporos Int. 2009 Aug;20(8):1363-7. doi: 10.1007/s00198-008-0787-8. Epub 2008 Nov 14.
Background: PubMed 40142693Lotan R, Moayad C, Sakhnini M, Rijini N, Goldstein AL, Hershkovich O. In-Hospital Proximal Femoral Fracture Mortality and Anesthesia: Do the First Postoperative 72 h Matter? J Clin Med. 2025 Mar 11;14(6):1885. doi: 10.3390/jcm14061885.
BackgroundChatzopoulos ST, Zafeiris CP. Epidemiology of hip fractures in Europe: Geographic variability. Journal of Research & Practice on the Musculoskeletal System (JRPMS). 2023 Dec 1;7(4).
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Magdalena Fleming, MD contact

00 48 509 995 408

m.fleming@spskgruca.pl

Rafał Kamiński, MD, PhD contact

0048 502 775 345

rkaminski@spskgruca.pl

Rafał Kamiński, MD, PhD study chair

Dept of Musculoskeletal Trauma Surg and Orthop, Gruca Orthopaedic and Trauma Teaching Hospital, CMKP

Magdalena Fleming, MD principal investigator

Dept of Anesthesiology, Gruca Orthopaedic and Trauma Teaching Hospital, CMKP

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Magdalena Fleming, MD (00 48 509 995 408, m.fleming@spskgruca.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mild hypotension (time frame: periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07358299, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.