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

Tanta University

Status: Not yet enrolling

Conditions: Spinal Anesthesia in Elderly Patients

Treatments: Procedure: Fractionated SA with isobaric and hyperbaric bupivacaine; Procedure: Conventional SA group; Procedure: Fractionated SA with hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT07288996

36264PR131034/10/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

108 participants in 3 patient groups

Fractionated SA with isobaric and hyperbaric bupivacaine

Experimental group

Description:

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.

Treatment:

Procedure: Fractionated SA with isobaric and hyperbaric bupivacaine

Fractionated SA with hyperbaric bupivacaine group

Active Comparator group

Description:

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.

Treatment:

Procedure: Fractionated SA with hyperbaric bupivacaine

Conventional SA group

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional SA group