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Clinical Trials/NCT00616044
NCT00616044
Unknown
Not Applicable

Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.

Sao Jose do Rio Preto Medical School1 site in 1 country240 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Sao Jose do Rio Preto Medical School
Enrollment
240
Locations
1
Primary Endpoint
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
Last Updated
18 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
January 2009
Last Updated
18 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sao Jose do Rio Preto Medical School

Eligibility 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.

Outcomes

Primary Outcomes

Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.

Time Frame: five years

Study Sites (1)

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