Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

Hip Fractures Clinical Trial

— Spinocath  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00616044
• Other study ID #: Imbelloni&Gouveia
• Secondary ID: Not applied
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2008
• Last updated: February 14, 2008
• Start date: March 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2008
• Source: Sao Jose do Rio Preto University
• Contact: Luiz E Imbelloni, MD
• Phone: 55.21.2521-9404
• Email: dr.imbelloni[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: January 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone
• Hip Fractures
• Knee Arthroplasty

Intervention

Procedure:
• continuous spinal anesthesia
bupivacaina isobaric 0.5%, 5 mg
• 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
• combined spinal epidural anesthesia
CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany

Locations

Country	Name	City	State
Brazil	SaoJoseRPU	São José do Rio Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.		five years	No