Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
Information source: Sao Jose do Rio Preto University
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Fractures; Knee Arthroplasty; Femur Fracture
Intervention: continuous spinal anesthesia (Procedure); Spinocath a catheter for continuous spinal anesthesia (Procedure); combined spinal epidural anesthesia (Procedure)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Sao Jose do Rio Preto University Official(s) and/or principal investigator(s):
Luiz E Imbelloni, MD, Principal Investigator, Affiliation: Sao Jose do Rio Preto University
Overall contact:
Luiz E Imbelloni, MD, Phone: 55.21.2521-9404, Email: dr.imbelloni@terra.com.br
Summary
In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA)
and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our
results suggest that both continuous spinal anesthesia and combined spinal epidural
anesthesia provide good surgical conditions with a low incidence of complications. The
sensory block level and hemodynamic changes were lesser with CSA.
Clinical Details
Official title: Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
Study design: Treatment, Randomized, Single Blind (Subject), Crossover Assignment
Primary outcome: Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
Detailed description:
240 patients scheduled for hip, knee arthroplasty or fracture of the femur were randomly
assigned to receive either CSA or CSE. Blocks were performed in the lateral position at L3-L4
interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory
and motor block, need for complementary doses of local anesthetic, degree of technical
difficulties, cardiocirculatory changes and post dural puncture headache were registered. At
the end of the surgery, the catheter was removed and CSF leak was evaluated.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Fractures repair of femur, or arthroplasty of either knee or hip
Exclusion Criteria:
- Hypovolemia
- Preexisting neurologic disease
- Coagulation disorders and/or administration of thromboprophylaxis less than eight
hours before the start of surgery
- Infection at the puncture site
- Agitation or delirium and the presence of a urinary bladder catheter.
Locations and Contacts
Luiz E Imbelloni, MD, Phone: 55.21.2521-9404, Email: dr.imbelloni@terra.com.br
SaoJoseRPU, São José do Rio Preto, São Paulo 15015.000, Brazil; Completed
Additional Information
Starting date: March 2008
Ending date: January 2009
Last updated: February 14, 2008
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