Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00616044
Recruitment Status : Unknown
Verified January 2008 by Sao Jose do Rio Preto Medical School.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2008
Last Update Posted : February 15, 2008
Sponsor:
Information provided by:
Sao Jose do Rio Preto Medical School

Tracking Information
First Submitted Date  ICMJE February 4, 2008
First Posted Date  ICMJE February 15, 2008
Last Update Posted Date February 15, 2008
Study Start Date  ICMJE March 2008
Estimated Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2008)
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. [ Time Frame: five years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
Official Title  ICMJE Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hip Fractures
  • Knee Arthroplasty
  • Femur Fracture
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 14, 2008)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2009
Estimated Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00616044
Other Study ID Numbers  ICMJE Imbelloni&Gouveia
Not applied
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party 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.
Study Sponsor  ICMJE Sao Jose do Rio Preto Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luiz E Imbelloni, MD Sao Jose do Rio Preto Medical School
PRS Account Sao Jose do Rio Preto Medical School
Verification Date January 2008

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