Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 240
- Locations
- 2
- Primary Endpoint
- Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported