Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

Institut Kassab d'Orthopédie

Status: Unknown

Conditions: Hypotension; Hip Fracture

Treatments: Drug: isobaric bupivacaine; Drug: hypobaric bupivacaine; Procedure: continuous spinal anesthesia; Drug: ephedrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02428257

P-2015008AR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged more than 65 years and scheduled for a surgical repair of a hip fracture.

Exclusion criteria

• contraindication to spinal anesthesia or peripheral nerve blocks including hemostasis anomalies, local infection, allergic reaction to local anesthetics.
• dementia.
• consent refusal.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

hypobaric

Experimental group

Description:

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.

Treatment:

Drug: ephedrine

Drug: hypobaric bupivacaine

Procedure: continuous spinal anesthesia

isobaric

Active Comparator group

Description:

continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine

Treatment:

Drug: ephedrine

Drug: isobaric bupivacaine

Procedure: continuous spinal anesthesia