Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

NCT ID: NCT00616044

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-01-31

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.

Conditions

Hip Fractures; Knee Arthroplasty; Femur Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

continuous spinal anesthesia

Intervention Type: PROCEDURE

bupivacaina isobaric 0.5%, 5 mg

Spinocath a catheter for continuous spinal anesthesia

Intervention Type: PROCEDURE

Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric

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.

Group Type: EXPERIMENTAL

Spinocath a catheter for continuous spinal anesthesia

Intervention Type: PROCEDURE

Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric

combined spinal epidural anesthesia

Intervention Type: PROCEDURE

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

Interventions

continuous spinal anesthesia

bupivacaina isobaric 0.5%, 5 mg

Intervention Type: 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

Intervention Type: PROCEDURE

combined spinal epidural anesthesia

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

Intervention Type: PROCEDURE

Other Intervention Names

Major orthopedic surgeries; Catheter for continuous spinal anesthesia; Catheter for combined spinal epidural anesthesia; Catheter for continuous spinal anesthesia; Catheter for combined spinal epidural anesthesia

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hospital de Base, São José do Rio Preto, São Paulo, Brazil.

Principal Investigators

Luiz E Imbelloni, MD

Role: PRINCIPAL_INVESTIGATOR

Sao Jose do Rio Preto Medical School

Locations

SaoJoseRPU

São José do Rio Preto, São Paulo, Brazil

Countries

Brazil

Central Contacts

Luiz E Imbelloni, MD

Role: CONTACT

dr.imbelloni@terra.com.br

55.21.2521-9404

Other Identifiers

Not applied

Identifier Type: -

Identifier Source: secondary_id

Imbelloni&Gouveia

Identifier Type: -

Identifier Source: org_study_id