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Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Sao Jose do Rio Preto University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT00616044
First received: February 4, 2008
Last updated: February 14, 2008
Last verified: January 2008
History of Changes

February 4, 2008
February 14, 2008
March 2008
February 2008   (final data collection date for primary outcome measure)
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. [ Time Frame: five years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Hip Fractures
  • Knee Arthroplasty
  • Femur Fracture
  • Procedure: continuous spinal anesthesia
    bupivacaina isobaric 0.5%, 5 mg
    Other Name: Major orthopedic surgeries
  • Procedure: Spinocath a catheter for continuous spinal anesthesia
    Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric
    Other Names:
    • Catheter for continuous spinal anesthesia
    • Catheter for combined spinal epidural anesthesia
  • Procedure: combined spinal epidural anesthesia
    CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany
    Other Names:
    • Catheter for continuous spinal anesthesia
    • Catheter for combined spinal epidural anesthesia
  • Experimental: CSA
    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.
    Interventions:
    • Procedure: continuous spinal anesthesia
    • Procedure: Spinocath a catheter for continuous spinal anesthesia
  • Experimental: CSE
    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.
    Interventions:
    • Procedure: Spinocath a catheter for continuous spinal anesthesia
    • Procedure: combined spinal epidural anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
240
January 2009
February 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact: Luiz E Imbelloni, MD 55.21.2521-9404 dr.imbelloni@terra.com.br
Brazil
 
NCT00616044
Imbelloni&Gouveia, Not applied
No
Luiz Eduardo Imbelloni, MD. Director of Institute Regional Anesthesia, Hospital de Base, São José do Rio Preto, São Paulo, Brazil., Hospital de Base, São José do Rio Preto, São Paulo, Brazil.
Sao Jose do Rio Preto University
Not Provided
Principal Investigator: Luiz E Imbelloni, MD Sao Jose do Rio Preto University
Sao Jose do Rio Preto University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP