Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

Sponsor

Institut Kassab d'Orthopédie (Other)

Overall Status

Unknown status

CT.gov ID

NCT02428257

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Fracture Hypotension	Procedure: continuous spinal anesthesia Drug: hypobaric bupivacaine Drug: isobaric bupivacaine Drug: ephedrine	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Hypobaric Rather Than Isobaric Bupivacaine to Prevent Anesthesia-induced Hypotension in Patients Undergoing Surgical Repair of Hip Fracture Under Continuous Spinal Anesthesia: a Prospective Randomized Controlled Study.

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hypobaric 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.	Procedure: continuous spinal anesthesia Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side. Drug: hypobaric bupivacaine hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water. Drug: ephedrine
Active Comparator: isobaric continuous spinal anesthesia with 2,5 mg boluses of 0.5% isboaric bupivacaine	Procedure: continuous spinal anesthesia Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side. Drug: isobaric bupivacaine 0.5% isobaric bupivacaine Drug: ephedrine

Arm

Intervention/Treatment

Experimental: hypobaric

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.

Procedure: continuous spinal anesthesia

Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side.

Drug: hypobaric bupivacaine

hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.

Drug: ephedrine

Active Comparator: isobaric

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

Procedure: continuous spinal anesthesia

Drug: isobaric bupivacaine

0.5% isobaric bupivacaine

Drug: ephedrine

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.