Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Antioquia
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Medellin, Antioquia, Colombia, 0057
- Hospital Universitario San Vicente Fundación
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Antiquia
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Medellín, Antiquia, Colombia, 050010
- Adriana Cadavid, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids
Exclusion Criteria:
- Under 18 years old
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain level measurement with Numeric Rate Score (NRS)
Tidsramme: 5 days
|
0-10 where 0 means no pain and 10 means maximum possible pain
|
5 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pinprick test
Tidsramme: 5 days
|
evaluation of superficial sensitivity in S1 dermatome positive or negative
|
5 days
|
|
catheter duration
Tidsramme: 5 days
|
number of days in which the catheter is functional
|
5 days
|
|
opioid consumption reduction
Tidsramme: 5 days
|
opioid consumption in morphine equivalence
|
5 days
|
|
Delirium
Tidsramme: 5 days
|
minimental test score from 0 to 30 points.
Delirium positive for less than 24
|
5 days
|
|
Nauseas and Vomit
Tidsramme: 5 days
|
yes or not present
|
5 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UdeA1006
Plan for individuelle deltakerdata (IPD)
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