Hip FracturesPhase 4NCT01961895
Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture
A Phase 4 study testing Continuous lumbar plexus (LP) block analgesia in people with Hip Fractures and Perioperative Myocardial Ischemia, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
Trial summary
The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures, Perioperative Myocardial Ischemia
- What is being tested?
- Continuous lumbar plexus (LP) block analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesChile
- Study dates
- May 2010to May 2012
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with hip fracture within 48 hours of evolution
- Known coronary artery disease:
- Previous myocardial infarction Chronic stable angina Atypical angina with positive exercise test for coronary flow failure. Evidence of coronary artery disease with ultrasound, scintigraphic or angiographic compatible
- Patients with at least two of the risk factors for coronary heart disease as defined by Wallace (1998)
Who cannot join
- Patients receiving orthopedic treatment.
- Patients with coagulopathy, clinic or laboratory.
- Patients with sepsis or infection of the catheter insertion site of lumbar plexus.
- Patients with neurological diseases evolving.
- Patients disoriented, or dementia.
- CKD stage IV National Kidney Foundation (2)
Show all 13Show fewer
- Glomerular filtration rate between 15 and 29 mL/min/1, 73 m2
- Patients unable to use the Numeric Rating Scale (NRS) to assess pain.
- Patients with non-sinus rhythm or conduction abnormalities (right bundle branch block or left, atrioventricular block) in the admission ECG
- Patients with pacemaker.
- Enrolled patients with acute coronary syndrome or decompensated cardiovascular disease at entry.
- Allergy to any of the drugs of the protocol.
- Inability to understand or unaided sign informed consent.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Division de Anestesia - Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Santiago Metropolitan, 8330024
About this study
Official title: Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.
The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
- Conditions
- Hip Fractures, Perioperative Myocardial Ischemia
- Being tested
- Continuous lumbar plexus (LP) block analgesia, Intravenous patient-controlled analgesia
- Keywords
- Continuous lumbar plexus (LP) block analgesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous lumbar plexus (LP) block analgesiaProcedure or surgery
Intravenous patient-controlled analgesiaDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous patient-controlled analgesia | Active comparator | Intravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes. Receives: Drug: Intravenous patient-controlled analgesia |
| Continuous lumbar plexus (LP) block analgesia | Experimental | Continuous lumbar plexus (LP) block analgesia. Continuous infusion of a solution of 0.1% bupivacaine in PCA mode, programmed at 8 ml / h.
Rescue bolus 5 ml and 30 minutes lockout Receives: Procedure: Continuous lumbar plexus (LP) block analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
Measured: 3 days
Secondary outcomes (5)
Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).
Measured: 3 days
hospital death
Measured: 3 days
Death at 30, 90 and 360 days after surgery
Measured: 1 year
Perioperative Pain Intensity, measured in numerical rating scale (NRS).
Measured: 3 days
Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startMay 2010
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961895
- Sponsor's protocol ID
- Altermatt 09-148
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Perioperative Continuous Lumbar Plexus Block Upon the Incidence of Ischemic Cardiovascular Events in Elderly Patients With Hip Fracture.
- ClinicalTrials.gov ID
- NCT01961895
- Acronym / sponsor ID
- Altermatt 09-148
- Conditions
- Hip Fractures, Perioperative Myocardial Ischemia
- Keywords
- Continuous lumbar plexus (LP) block analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- First posted
- 14 Oct 2013 (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.
The purpose of this study is evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous patient-controlled analgesia | Active comparator | Drug: Intravenous patient-controlled analgesiaIntravenous morphine solution 0.2 mg / ml in PCA mode without basal infusion, 1mg bolus demand and lockout of 8 minutes. |
| Continuous lumbar plexus (LP) block analgesia | Experimental | Procedure: Continuous lumbar plexus (LP) block analgesiaContinuous lumbar plexus (LP) block analgesia. Continuous infusion of a solution of 0.1% bupivacaine in PCA mode, programmed at 8 ml / h. Rescue bolus 5 ml and 30 minutes lockout |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hip fracture within 48 hours of evolution
- Known coronary artery disease:
- Previous myocardial infarction Chronic stable angina Atypical angina with positive exercise test for coronary flow failure. Evidence of coronary artery disease with ultrasound, scintigraphic or angiographic compatible
- Patients with at least two of the risk factors for coronary heart disease as defined by Wallace (1998)
Key exclusion criteria (13 listed)
- Patients receiving orthopedic treatment.
- Patients with coagulopathy, clinic or laboratory.
- Patients with sepsis or infection of the catheter insertion site of lumbar plexus.
- Patients with neurological diseases evolving.
- Patients disoriented, or dementia.
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 lumbar plexus (LP) block analgesia | Procedure or surgery | Continuous lumbar plexus (LP) block analgesia |
| Intravenous patient-controlled analgesia | Drug | Intravenous patient-controlled analgesia |
Primary outcome
evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject.
Time frame: 3 days
5 secondary outcomes
Major cardiovascular events (myocardial infarction, acute pulmonary edema, arrhythmias).
Time frame: 3 days
hospital death
Time frame: 3 days
Death at 30, 90 and 360 days after surgery
Time frame: 1 year
Perioperative Pain Intensity, measured in numerical rating scale (NRS).
Time frame: 3 days
Evaluate Adverse events (hypotension, respiratory depression, systemic toxicity, etc..)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Derived from this study: PubMed 33238043Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous lumbar plexus (LP) block analgesia in people with Hip Fractures and Perioperative Myocardial Ischemia, run by Pontificia Universidad Catolica de Chile at 2 sites in Chile.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the efficacy of perioperative continuous lumbar plexus block in reducing the risk of cardiac ischemic events of elderly patients undergoing surgery for hip fractures, expressed as a reduction of ischemic events per subject. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01961895, which also lists 1 linked publication.
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 14 Oct 2013.