Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Sao Jose do Rio Preto University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT00616044
First received: February 4, 2008
Last updated: February 14, 2008
Last verified: January 2008
  Purpose

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 Intervention
Hip Fractures
Knee Arthroplasty
Femur Fracture
Procedure: continuous spinal anesthesia
Procedure: Spinocath a catheter for continuous spinal anesthesia
Procedure: combined spinal epidural anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.

Resource links provided by NLM:


Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:
  • Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 University
Investigators
Principal Investigator: Luiz E Imbelloni, MD Sao Jose do Rio Preto University
  More Information

No publications provided

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
Study First Received: February 4, 2008
Last Updated: February 14, 2008
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Sao Jose do Rio Preto University:
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014