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Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

Information source: Institut Kassab d'Orthopédie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hip Fracture; Hypotension

Intervention: continuous spinal anesthesia (Procedure); hypobaric bupivacaine (Drug); isobaric bupivacaine (Drug); ephedrine (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Institut Kassab d'Orthopédie

Overall contact:
Karim Raies, A. Professor, Phone: +21655208602, Email: karim.raies@gmail.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: 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

Secondary outcome:

Total bupivacaine consumption

The percentage of patients who experienced at least one episode of bradycardia (heart rate<50 bpm) among the 2 groups

vasopressor use

fluid infusion

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.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Karim Raies, A. Professor, Phone: +21655208602, Email: karim.raies@gmail.com

Institut Kassab d'Orthopédie, La Manouba, Tunisia; Not yet recruiting
Olfa Kaabachi, Professor, Phone: +21698317381, Email: olfa.kaabachi@gnet.tn
Additional Information

Related publications:

Neuman MD, Rosenbaum PR, Ludwig JM, Zubizarreta JR, Silber JH. Anesthesia technique, mortality, and length of stay after hip fracture surgery. JAMA. 2014 Jun 25;311(24):2508-17. doi: 10.1001/jama.2014.6499.

Patorno E, Neuman MD, Schneeweiss S, Mogun H, Bateman BT. Comparative safety of anesthetic type for hip fracture surgery in adults: retrospective cohort study. BMJ. 2014 Jun 27;348:g4022. doi: 10.1136/bmj.g4022.

Starting date: June 2015
Last updated: April 27, 2015

Page last updated: August 23, 2015

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