- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04278014
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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Antioquia
-
Medellin, Antioquia, Colombia, 0057
- Hospital Universitario San Vicente Fundación
-
-
Antiquia
-
Medellín, Antiquia, Colombia, 050010
- Adriana Cadavid, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain level measurement with Numeric Rate Score (NRS)
Tidsram: 5 days
|
0-10 where 0 means no pain and 10 means maximum possible pain
|
5 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pinprick test
Tidsram: 5 days
|
evaluation of superficial sensitivity in S1 dermatome positive or negative
|
5 days
|
|
catheter duration
Tidsram: 5 days
|
number of days in which the catheter is functional
|
5 days
|
|
opioid consumption reduction
Tidsram: 5 days
|
opioid consumption in morphine equivalence
|
5 days
|
|
Delirium
Tidsram: 5 days
|
minimental test score from 0 to 30 points.
Delirium positive for less than 24
|
5 days
|
|
Nauseas and Vomit
Tidsram: 5 days
|
yes or not present
|
5 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UdeA1006
Plan för individuella deltagardata (IPD)
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