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

NCT07358299 | Not Yet Recruiting Phase 4

• 1 other identifier: No. 65/2025 of 16 July 2025
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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 Most existing studies are over two decades old, based on small cohorts and outdated anaesthetic protocols, and lack long-term follow-up data (\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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Severe hypotension

  periprocedural

• Hypotension associated with organ complications

  periprocedural

• Advanced hemodynamic measurements

  periprocedural

• Bradycardia

  periprocedural

• Hypotension-related complications

  through hospitalisation completion, an average of 1 week

Study Arms (2)

Single-shot spinal anaesthesia

EXPERIMENTAL

Bolus dose of Bupivacaine Spinal 0,5% Heavy

Drug: Bupivacaine Spinal 0,5% Heavy - bolus

Continuous spinal anaesthesia

EXPERIMENTAL

Dose titration of Bupivacaine Spinal 0,5% Heavy

Drug: Bupivacaine Spinal 0,5% Heavy - titration

Interventions

Bupivacaine Spinal 0,5% Heavy - titration DRUG

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

Continuous spinal anaesthesia

Bupivacaine Spinal 0,5% Heavy - bolus DRUG

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

Single-shot spinal anaesthesia

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead
• Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland: collaborator

Study Sites (2)

Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital, Konarskiego 13 street

Otwock, 05-400, Poland

Location

National Medical Institute of the Ministry of the Interior and Administration, Wołoska 137 street

Warsaw, 02507, Poland

Location

Related Publications (12)

• 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.

  PMID: 33936949 BACKGROUND

• 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.

  PMID: 8561333 BACKGROUND

• 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.

  PMID: 16632842 BACKGROUND

• 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.

  PMID: 38242801 BACKGROUND

• 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.

  PMID: 38137582 BACKGROUND

• 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.

  PMID: 39463540 BACKGROUND

• 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.

  PMID: 31722793 BACKGROUND

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

  PMID: 33576588 BACKGROUND

• 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.

  PMID: 24090926 BACKGROUND

• 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.

  PMID: 19009330 BACKGROUND

• 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.

  PMID: 40142693 BACKGROUND

• 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).

  BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Rafał Kamiński, MD, PhD

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

  STUDY CHAIR

• Magdalena Fleming, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor, Chief of the Department of Orthopaedic and Trauma Surgery (Div. Knee Surg & Arthroscopy, Div. General Orthop Trauma, Div. Upper Limb Surg.) at Gruca Orthopaedic And Trauma Teaching Hospital

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: January 22, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)