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Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02428257
Enrollment
120
Registered
2015-04-28
Start date
2015-06-30
Completion date
2015-12-31
Last updated
2015-04-28

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

Conditions

Hip Fracture, Hypotension

Keywords

hip fracture, elderly, continous spinal anesthesia, hypobaric bupivacaine, isobaric bupivacaine, hypotension

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.

Interventions

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.

DRUGhypobaric bupivacaine

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

0.5% isobaric bupivacaine

DRUGephedrine

Sponsors

Institut Kassab d'Orthopédie
Lead SponsorOTHER

Study design

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

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frame
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 groups2 hours

Secondary

MeasureTime frameDescription
Total bupivacaine consumption2 hourstotal 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 groups2 hours
vasopressor use2 hourstotal ephedrine injected if hypotension occurred (approximate duration of surgery : 2 hours).
fluid infusion2 hourstotal fluid infused intravenously at the end of surgery (approximate duration of surgery : 2 hours).

Countries

Tunisia

Contacts

Primary ContactKarim Raies, A. Professor
karim.raies@gmail.com+21655208602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026