Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616044

Acronym

Spinocath

Enrollment

240

Registered

2008-02-15

Start date

2008-03-31

Completion date

2009-01-31

Last updated

2008-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur Fracture, Hip Fractures, Knee Arthroplasty

Keywords

Spinal Anesthesia, Epidural Anesthesia, Orthopedic procedures

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.

Interventions

PROCEDUREcontinuous spinal anesthesia

bupivacaina isobaric 0.5%, 5 mg

PROCEDURESpinocath 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

PROCEDUREcombined spinal epidural anesthesia

CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.	five years

Countries

Brazil

Contacts

Primary ContactLuiz E Imbelloni, MD

dr.imbelloni@terra.com.br55.21.2521-9404

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026