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Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

S

Sao Jose do Rio Preto Medical School

Status

Unknown

Conditions

Knee Arthroplasty
Hip Fractures
Femur Fracture

Treatments

Procedure: combined spinal epidural anesthesia
Procedure: continuous spinal anesthesia
Procedure: Spinocath a catheter for continuous spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT00616044
Not applied
Imbelloni&Gouveia

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

240 participants in 2 patient groups

CSA
Experimental group
Description:
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.
Treatment:
Procedure: Spinocath a catheter for continuous spinal anesthesia
Procedure: continuous spinal anesthesia
CSE
Experimental group
Description:
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.
Treatment:
Procedure: Spinocath a catheter for continuous spinal anesthesia
Procedure: combined spinal epidural anesthesia

Trial contacts and locations

1

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Central trial contact

Luiz E Imbelloni, MD

Data sourced from clinicaltrials.gov

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