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NCT Number: NCT07288996

Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine for Elderly Hip Fracture Patients

This prospective randomized controlled study will be conducted to compare the effect of fractionated SA using isobaric and hyperbaric bupivacaine with fractionated SA using hyperbaric bupivacaine and the conventional SA on hemodynamic instability in orthogeriatric patients undergoing hip fracture surgeries.

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Key information

Conditions

Spinal Anesthesia in Elderly Patients

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta university hospital

Tanta, Egypt

About this study

Hip fractures are one of the most common reasons for elderly patients to present to the emergency department and require urgent surgery. Despite the debate regarding the preferred type of anesthesia in the elderly population, spinal anesthesia has shown the advantage of the simplicity of the technique, the better analgesic profile, the lower incidence of thromboembolic events and lower hospital stay. Hemodynamic stability should be considered as a primary intraoperative target. In pursuit of optimizing spinal anesthesia, this study proposed that fractionated SA by sequential administration of low doses of isobaric and hyperbaric bupivacaine can minimize hemodynamic instability while leveraging the advantages of both solutions when compared with fractionated SA using hyperbaric bupivacaine or the conventional SA technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderly patients of both gender aged 65 years or more with American Society of Anesthesiologists (ASA) Physical Status I-III, who were scheduled for hip fracture surgeries under Spinal anesthesia

Exclusion criteria

  • Patients declined to participate in the trial.
  • Patients on anticoagulation therapy.
  • Patients planned for general anesthesia.
  • Patients with atrial fibrillation.
  • Allergies or hypersensitivity to local anesthetic drugs.
  • Spinal cord deformities.
  • Infection that contraindicate SA.
  • Preoperative motor and sensory deficits

Treatment and study plan

Fractionated SA with isobaric and hyperbaric bupivacaine

Procedure

patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine.

Other names: Arm 1

Fractionated SA with hyperbaric bupivacaine

Procedure

patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds.

Other names: Arm 2

Conventional SA group

Procedure

patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.

Other names: Arm 3

Primary outcomes

  1. Incidence of intraoperative hypotension

    Time frame: MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.

    Intraoperative hypotension is defined as the drop of systolic blood pressure (SBP) by 25% of the basal reading or the drop of MAP below 65 mmHg.

Secondary outcomes

  1. Incidence of bradycardia.

    Time frame: HR will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.

    Bradycardia is defined as sustained HR less than 60 beat/ minute

  2. Vasopressor requirements.

    Time frame: intraoperatively after spinal anesthesia till the end of surgical intervention

    total dose of vasopressors required intraoperatively

  3. Postoperative pain score

    Time frame: immediately post operatively then every 30 minutes up to 2 hour

    Visual analogue scale (VAS) is typically a 10-cm horizontal line labeled:

    • 0 = No pain
    • 10 = Worst imaginable pain

    A patient marks a point along the line to indicate their level of pain. The score is then measured in centimeters or millimeters to quantify pain intensity.

  4. Time to first rescue analgesia

    Time frame: post operative .. time interval from the end of surgery until need of rescue analgesia

    time interval from the end of surgery until need of rescue analgesia

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine Toward Safer Anesthesia for Elderly Hip Fracture Patients: Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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