Critical Limb IschemiaNCT04278014
Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
An observational study of Critical Limb Ischemia, run by Universidad de Antioquia at 2 sites in Colombia.
Trial summary
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications. ultrasound-guided continuous sciatic block (CCBN) is strategy effective and safe to consider in this patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- ultrasound-guided continuous sciatic block with longitudinal approach
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Jun 2020to 1 Feb 2021
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids over 18 years old who accept the interventional technique
Who may be able to join
- Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids
Who cannot join
- Under 18 years old
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
hospital universitario San Vicente Fundacion
Medellín, Antioquia, 0057
Adriana Cadavid, MD
Medellín, Antiquia, 050010
About this study
Official title: Evaluation of Ultrasound Guided Continuous Sciatic Block Nerve With a Longitudinal Approach in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients : Prospective Descriptive Study of Exploratory Cohort
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications. ultrasound-guided continuous sciatic block (CCBN) is strategy effective and safe to consider in this patients.
This prospective descriptive exploratory cohort study evaluates CCBN as a effective therapeutic tools for patients whit (CLI)
Read the detailed description
Critical limb ischemia is the final stage of peripheral vascular disease identified by resting pain greater than 2 weeks with ulcers or gangrene in 1 or both extremities. Pain relief is a therapeutic challenge due to its severity, which significantly affects the quality of life, and the comorbidities that occur frequently in these patients, which limits the use of analgesics medications. Regional techniques can play an important role as they are safe and effective in analgesic management . Within these we find the ultrasound guided continuous sciatic block as a strategy to consider in the periods of exacerbation of pain, as a bridge to a palliative or resolutive management.
Prospective descriptive exploratory cohort study.
Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids will be included. A continuous ultrasound-guided sciatic nerve block with longitudinal approach will be performed, with no anti-aggregation or anticoagulation suspension, continuing with an infusion of Bupivacaine 0.1%
The primary outcome will be numerical pain rating scale (NPrs) and secondary outcome Pinprick test, catheter duration, opioid consumption reduction and side effects to it.
- Conditions
- Critical Limb Ischemia
- Being tested
- ultrasound-guided continuous sciatic block with longitudinal approach
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided continuous sciatic block with longitudinal approachProcedure or surgery
ultrasound-guided continuous sciatic block with longitudinal approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level measurement with Numeric Rate Score (NRS)
0-10 where 0 means no pain and 10 means maximum possible pain
Measured: 5 days
Secondary outcomes (5)
Pinprick test
evaluation of superficial sensitivity in S1 dermatome positive or negative
Measured: 5 days
catheter duration
number of days in which the catheter is functional
Measured: 5 days
opioid consumption reduction
opioid consumption in morphine equivalence
Measured: 5 days
Delirium
minimental test score from 0 to 30 points. Delirium positive for less than 24
Measured: 5 days
Nauseas and Vomit
yes or not present
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jun 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278014
- Sponsor's protocol ID
- UdeA1006
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2020
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Guided Continuous Sciatic Block Nerve With a Longitudinal Approach in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients : Prospective Descriptive Study of Exploratory Cohort
- ClinicalTrials.gov ID
- NCT04278014
- Acronym / sponsor ID
- UdeA1006
- Conditions
- Critical Limb Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- 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.
Critical limb ischemia (CLI) is associated with severe pain that is a therapeutic challenge whit therapeutic limits for the use of conventional analgesics medications. ultrasound-guided continuous sciatic block (CCBN) is strategy effective and safe to consider in this patients.
This prospective descriptive exploratory cohort study evaluates CCBN as a effective therapeutic tools for patients whit (CLI)
Detailed description
Critical limb ischemia is the final stage of peripheral vascular disease identified by resting pain greater than 2 weeks with ulcers or gangrene in 1 or both extremities. Pain relief is a therapeutic challenge due to its severity, which significantly affects the quality of life, and the comorbidities that occur frequently in these patients, which limits the use of analgesics medications. Regional techniques can play an important role as they are safe and effective in analgesic management . Within these we find the ultrasound guided continuous sciatic block as a strategy to consider in the periods of exacerbation of pain, as a bridge to a palliative or resolutive management.
Prospective descriptive exploratory cohort study.
Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids will be included. A continuous ultrasound-guided sciatic nerve block with longitudinal approach will be performed, with no anti-aggregation or anticoagulation suspension, continuing with an infusion of Bupivacaine 0.1%
The primary outcome will be numerical pain rating scale (NPrs) and secondary outcome Pinprick test, catheter duration, opioid consumption reduction and side effects to it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids over 18 years old who accept the interventional technique
Key inclusion criteria (1 listed)
- Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids
Key exclusion criteria (1 listed)
- Under 18 years old
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 |
|---|---|---|
| ultrasound-guided continuous sciatic block with longitudinal approachultrasound-guided continuous sciatic block with longitudinal approach | Procedure or surgery | – |
Primary outcome
Pain level measurement with Numeric Rate Score (NRS)
Time frame: 5 days
0-10 where 0 means no pain and 10 means maximum possible pain
5 secondary outcomes
Pinprick test
Time frame: 5 days
catheter duration
Time frame: 5 days
opioid consumption reduction
Time frame: 5 days
Delirium
Time frame: 5 days
Nauseas and Vomit
Time frame: 5 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 5 May 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Critical Limb Ischemia, run by Universidad de Antioquia at 2 sites in Colombia.
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 1 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 5 May 2021. 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 Colombia. 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?
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?
Pain level measurement with Numeric Rate Score (NRS) (time frame: 5 days). 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 5 May 2021.