Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hip Fractures, Knee Arthroplasty, Femur Fracture

Intervention / Treatment
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* Procedure: continuous spinal anesthesia
* Procedure: Spinocath a catheter for continuous spinal anesthesia
* Procedure: combined spinal epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CSA<br>For CSA, an 22-G catheter (Spinocath, B.Braun Melsungen, Germany) over a 27-G Quincke needle was used. After identification of the epidural space with a Crawford needle, the catheter with the spinal needle inside was advanced through the epidural space until the dural puncture was felt and CSF was seen in the catheter. The catheter was then fed over the needle into the intrathecal space. The spinal needle and the modified Tuohy needle were removed and a luer connector and a filter previously filled with the anesthetic solution were attached to the catheter. | Procedure: continuous spinal anesthesia<br>* bupivacaina isobaric 0.5%, 5 mg<br>* Other names: Major orthopedic surgeries;Procedure: Spinocath a catheter for continuous spinal anesthesia<br>* Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric<br>* Other names: Catheter for combined spinal epidural anesthesia;|
| Experimental: CSE<br>CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany). The block consists of performing a spinal block via a 27-G spinal needle (Spinocan 125mm) introduced through an 18-G Tuohy needle (Perican 88mm) which was placed cranially directed in the epidural space. We did rotate the Tuohy needle between the spinal block and the insertion of the epidural catheter. | Procedure: Spinocath a catheter for continuous spinal anesthesia<br>* Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric<br>* Other names: Catheter for combined spinal epidural anesthesia;Procedure: combined spinal epidural anesthesia<br>* CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany<br>* Other names: Catheter for combined spinal epidural anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. |  | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Anesthesia, Epidural Anesthesia, Orthopedic procedures