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

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Most existing studies are over two decades old, based on small cohorts and outdated anaesthetic protocols, and lack long-term follow-up data (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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Fractures; Anesthesia, Spinal
• Intervention / Treatment: Drug: Bupivacaine Spinal 0,5% Heavy - bolus; Drug: Bupivacaine Spinal 0,5% Heavy - titration

Detailed Description

Study Flow Diagram.

1. 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):

     1. Both groups: Ultrasound-guided femoral nerve block with 10 ml of 0.5% ropivacaine.
     2. 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.
     3. 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.

2. Intraoperative Monitoring of Vital Signs:

   1. 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.

   2. 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.

3. Monitoring in the Post-Anesthesia Care Unit (PACU):

   1. Continuation of standard vital signs monitoring (HR, BP, SpO2).
   2. 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.
   3. 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 .

4. 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 .

5. 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.
6. 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 .

7. Complications associated with spinal anesthesia:

   1. Postoperative nausea and vomiting (PONV)
   2. 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 palsy
   11. Cauda equina syndrome
   12. Spinal hematoma or hygroma
   13. Intracranial hypotension syndrome
   14. Central nervous system infection
   15. Other

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Magdalena Fleming, MD; Phone Number: 00 48 509 995 408; Email: m.fleming@spskgruca.pl
• Study Contact Backup: Name: Rafał Kamiński, MD, PhD; Phone Number: 0048 502 775 345; Email: rkaminski@spskgruca.pl

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-shot spinal anaesthesia; Bolus dose of Bupivacaine Spinal 0,5% Heavy	Drug: Bupivacaine Spinal 0,5% Heavy - 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.; Other Names: Single bolus
Experimental: Continuous spinal anaesthesia; Dose titration of Bupivacaine Spinal 0,5% Heavy	Drug: Bupivacaine Spinal 0,5% Heavy - 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.; Other Names: Rose titration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	periprocedural
Hypotension-related complications	Comparison of the risk of hypotension-related complications between the study groups: Delirium; Acute kidney injury (AKI)	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	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	0, 1mth, 3mth, 6mth, 12mth, 24mth
Complications associated with spinal anesthesia:	Comparison of the risk of complications associated with spinal anesthesia: Postoperative nausea and vomiting (PONV); Decrease in body temperature / 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 dysfunction; Cauda equina syndrome; Spinal hematoma or hygroma; Intracranial hypotension syndrome; Central nervous system infection; Other	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	through hospitalisation completion, an average of 1 week
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); Complete block (unable to move feet or knees); Almost complete block (able to move feet only); Partial block (just able to move knees); Detectable weakness of hip flexion while supine (full flexion of knees); No detectable weakness of hip flexion while supine; Able to perform partial knee bend	periprocedural
Other complications associated with the studied types of anesthesia	Comparison of the risk of other complications associated with the studied types of anesthesia	0 month, 1 month, 3 month, 6 month, 12 month, 24 month
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	0 month, 1 month, 3 month, 6 month, 12 month, 24 month

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education
• Collaborators: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Investigators: Study Chair: Rafał Kamiński, MD, PhD, Dept of Musculoskeletal Trauma Surg and Orthop, Gruca Orthopaedic and Trauma Teaching Hospital, CMKP; Principal Investigator: Magdalena Fleming, MD, Dept of Anesthesiology, Gruca Orthopaedic and Trauma Teaching Hospital, CMKP

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Stachurski J, Sionek A. Epidemiology of femoral shaft fractures in Poland. Przegl Epidemiol. 2020;74(3):492-502. doi: 10.32394/pe.74.43.
• 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.
• 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.
• 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.
• 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).

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: No. 65/2025 of 16 July 2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No