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Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block (Spinocath)

Primary Purpose

Hip Fractures, Knee Arthroplasty, Femur Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
continuous spinal anesthesia
Spinocath a catheter for continuous spinal anesthesia
combined spinal epidural anesthesia
Sponsored by
Sao Jose do Rio Preto Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Spinal Anesthesia, Epidural Anesthesia, Orthopedic procedures

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • SaoJoseRPU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CSA

CSE

Arm 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.

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.

Outcomes

Primary Outcome Measures

Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2008
Last Updated
February 14, 2008
Sponsor
Sao Jose do Rio Preto Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00616044
Brief Title
Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
Acronym
Spinocath
Official Title
Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sao Jose do Rio Preto Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Knee Arthroplasty, Femur Fracture
Keywords
Spinal Anesthesia, Epidural Anesthesia, Orthopedic procedures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSA
Arm Type
Experimental
Arm 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.
Arm Title
CSE
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
continuous spinal anesthesia
Other Intervention Name(s)
Major orthopedic surgeries
Intervention Description
bupivacaina isobaric 0.5%, 5 mg
Intervention Type
Procedure
Intervention Name(s)
Spinocath a catheter for continuous spinal anesthesia
Other Intervention Name(s)
Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesia
Intervention Description
Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric
Intervention Type
Procedure
Intervention Name(s)
combined spinal epidural anesthesia
Other Intervention Name(s)
Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesia
Intervention Description
CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany
Primary Outcome Measure Information:
Title
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz E Imbelloni, MD
Phone
55.21.2521-9404
Email
dr.imbelloni@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz E Imbelloni, MD
Organizational Affiliation
Sao Jose do Rio Preto Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
SaoJoseRPU
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15015.000
Country
Brazil

12. IPD Sharing Statement

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Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block

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