NCT00616044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 15, 2008

Status Verified

January 1, 2008

First QC Date

February 4, 2008

Last Update Submit

February 14, 2008

Conditions

Hip FracturesKnee ArthroplastyFemur Fracture

Keywords

Spinal AnesthesiaEpidural AnesthesiaOrthopedic procedures

Outcome Measures

Primary Outcomes (1)

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

    five years

Study Arms (2)

CSA

EXPERIMENTAL

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 anesthesiaProcedure: Spinocath a catheter for continuous spinal anesthesia

CSE

EXPERIMENTAL

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 anesthesiaProcedure: combined spinal epidural anesthesia

Interventions

continuous spinal anesthesiaPROCEDURE

bupivacaina isobaric 0.5%, 5 mg

Also known as: Major orthopedic surgeries
CSA
Spinocath a catheter for continuous spinal anesthesiaPROCEDURE

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

Also known as: Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesia
CSACSE
combined spinal epidural anesthesiaPROCEDURE

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

Also known as: Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesia
CSE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fractures repair of femur, or arthroplasty of either knee or hip

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SaoJoseRPU

São José do Rio Preto, São Paulo, 15015.000, Brazil

Location

MeSH Terms

Conditions

Hip FracturesFemoral Fractures

Interventions

Catheters

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Luiz E Imbelloni, MD

    Sao Jose do Rio Preto Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz E Imbelloni, MD

CONTACT

55.21.2521-9404dr.imbelloni@terra.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2008

Study Completion

January 1, 2009

Last Updated

February 15, 2008

Record last verified: 2008-01

Locations

BR(1)