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Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

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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

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.

Condition or disease Intervention/treatment Phase
Hip Fractures Knee Arthroplasty Femur Fracture Procedure: continuous spinal anesthesia Procedure: Spinocath a catheter for continuous spinal anesthesia Procedure: combined spinal epidural anesthesia Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
Study Start Date : March 2008
Estimated Primary Completion Date : February 2008
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. [ Time Frame: five years ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616044


Contacts
Contact: Luiz E Imbelloni, MD 55.21.2521-9404 dr.imbelloni@terra.com.br

Locations
Brazil
SaoJoseRPU Completed
São José do Rio Preto, São Paulo, Brazil, 15015.000
Sponsors and Collaborators
Sao Jose do Rio Preto Medical School
Investigators
Principal Investigator: Luiz E Imbelloni, MD Sao Jose do Rio Preto Medical School

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.
ClinicalTrials.gov Identifier: NCT00616044     History of Changes
Other Study ID Numbers: Imbelloni&Gouveia
Not applied
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: January 2008

Keywords provided by Sao Jose do Rio Preto Medical School:
Spinal Anesthesia
Epidural Anesthesia
Orthopedic procedures

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Hip Injuries
Leg Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs