Hip FracturesSpinocathNCT00616044
Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block
A study testing continuous spinal anesthesia, Spinocath a catheter for continuous spinal anesthesia and combined spinal epidural anesthesia in people with Hip Fractures and Knee Arthroplasty, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hip Fractures, Knee Arthroplasty, Femur Fracture
- What is being tested?
- continuous spinal anesthesia, Spinocath a catheter for continuous spinal anesthesia and combined spinal epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fractures repair of femur, or arthroplasty of either knee or hip
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
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.
Read the 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
- Being tested
- continuous spinal anesthesia, Spinocath a catheter for continuous spinal anesthesia, combined spinal epidural anesthesia
- Keywords
- Spinal Anesthesia, Epidural Anesthesia, Orthopedic procedures
- Medical subject headings
- Hip Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous spinal anesthesiaProcedure or surgery
Also called Major orthopedic surgeries
bupivacaina isobaric 0.5%, 5 mg
Spinocath a catheter for continuous spinal anesthesiaProcedure or surgery
Also called Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesia
Continuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric
combined spinal epidural anesthesiaProcedure or surgery
Also called Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesia
CSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: continuous spinal anesthesia; Procedure: 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. Receives: Procedure: Spinocath a catheter for continuous spinal anesthesia; Procedure: combined spinal epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2008 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Luiz E Imbelloni, MD, Principal investigator, Sao Jose do Rio Preto Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616044
- Sponsor's protocol ID
- Imbelloni&Gouveia
- Other IDs
- Not applied
- Acronym
- Spinocath
- Status last verified
- Jan 2008
- First submitted
- 4 Feb 2008
- Last updated
- 15 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.
- ClinicalTrials.gov ID
- NCT00616044
- Acronym / sponsor ID
- Spinocath / Imbelloni&Gouveia
- Conditions
- Hip Fractures, Knee Arthroplasty, Femur Fracture
- Keywords
- Spinal Anesthesia, Epidural Anesthesia, Orthopedic procedures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSA | Experimental | Procedure: continuous spinal anesthesia, Procedure: Spinocath a catheter for continuous spinal anesthesiaFor 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 | Experimental | Procedure: Spinocath a catheter for continuous spinal anesthesia, Procedure: combined spinal epidural anesthesiaCSE 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fractures repair of femur, or arthroplasty of either knee or hip
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous spinal anesthesiaAlso: Major orthopedic surgeriesbupivacaina isobaric 0.5%, 5 mg | Procedure or surgery | CSA |
| Spinocath a catheter for continuous spinal anesthesiaAlso: Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesiaContinuous spinal anesthesia with low dose of bupivacaine isobaric Combined epidural spinal anesthesia with low dose of bupivacaine isobaric | Procedure or surgery | CSA, CSE |
| combined spinal epidural anesthesiaAlso: Catheter for continuous spinal anesthesia, Catheter for combined spinal epidural anesthesiaCSE was performed with the needle-through-needle technique using a single interspace (Espocan, B.Braun Melsungen, Germany | Procedure or surgery | CSE |
Primary outcome
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz E Imbelloni, MD principal investigator
Sao Jose do Rio Preto Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous spinal anesthesia, Spinocath a catheter for continuous spinal anesthesia and combined spinal epidural anesthesia in people with Hip Fractures and Knee Arthroplasty, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz E Imbelloni, MD (55.21.2521-9404, dr.imbelloni@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries. (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2008.