Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly
- Conditions
- Hip FractureHypotension
- Interventions
- Procedure: continuous spinal anesthesia
- Registration Number
- NCT02428257
- Lead Sponsor
- Institut Kassab d'Orthopédie
- Brief Summary
The study evaluates the potential beneficial effects on hemodynamics when hypobaric bupivacaine is used instead of isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture in elderly patients. Half of the patients will receive hypobaric bupivacaine and the over half will reveive isobaric bupivacaine and hemodynamic data will be compared.
- Detailed Description
Anesthesia for surgical repair of hip fracture is still controversial. Large retrospective studies and systematic reviews failed to demonstrate the superiority of either general or regional anesthesia. However, continuous spinal anesthesia has been shown to preserve hemodynamics better than general and single shoot spinal anesthesia. However, hypotension still occurs with continuous spinal anesthesia.
Unilateral spinal anesthesia may be achieved by hypobaric bupivacaine when patients are in the lateral position. Unilateral spinal anesthesia is more effective in preserving hemodynamics by limiting the spread of the sympathetic blockade to the operated side.
Our goal is to show that the use of hypobaric rather than isobaric bupivacaine in continuous spinal anesthesia for surgical repair of hip fracture reduces incidence of hypotension.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Patients aged more than 65 years and scheduled for a surgical repair of a hip fracture.
- contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics.
- dementia.
- consent refusal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description isobaric isobaric bupivacaine continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine hypobaric continuous spinal anesthesia continuous spinal anesthesia with 2,5 mg boluses of hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water. hypobaric hypobaric bupivacaine continuous spinal anesthesia with 2,5 mg boluses of hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water. isobaric continuous spinal anesthesia continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine hypobaric ephedrine continuous spinal anesthesia with 2,5 mg boluses of hypobaric bupivacaine, prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water. isobaric ephedrine continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine
- Primary Outcome Measures
Name Time Method The percentage of patients who experienced at least one episode of hypotension during surgery (fall of more than 20% of systolic blood pressure) among the 2 groups 2 hours
- Secondary Outcome Measures
Name Time Method Total bupivacaine consumption 2 hours total dose of bupivacaine needed to perform the surgery (approximate duration of surgery : 2 hours)
The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups 2 hours vasopressor use 2 hours total ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).
fluid infusion 2 hours total fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).
Trial Locations
- Locations (1)
Institut Kassab d'Orthopédie
🇹🇳La Manouba, Tunisia