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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07288996
Enrollment
108
Registered
2025-12-17
Start date
2025-12-20
Completion date
2026-06-20
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia in Elderly Patients

Keywords

Fractionated spinal anesthesia, hyperbaric bupivacaine, isobaric bupivacaine, hip fructure, elderly patients

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREFractionated SA with isobaric and hyperbaric bupivacaine

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.

PROCEDUREFractionated SA with hyperbaric bupivacaine

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.

PROCEDUREConventional SA group

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of intraoperative hypotensionMAP 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

MeasureTime frameDescription
Incidence of bradycardia.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
Vasopressor requirements.intraoperatively after spinal anesthesia till the end of surgical interventiontotal dose of vasopressors required intraoperatively
Postoperative pain scoreimmediately post operatively then every 30 minutes up to 2 hourVisual 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.
Time to first rescue analgesiapost operative .. time interval from the end of surgery until need of rescue analgesiatime interval from the end of surgery until need of rescue analgesia

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026