Clinical trial NCT04278014: Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Limb Ischemia
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain level measurement with Numeric Rate Score (NRS)
timeFrame: 5 days
Secondary outcomes:
measure: Pinprick test
timeFrame: 5 days
measure: catheter duration
timeFrame: 5 days
measure: opioid consumption reduction
timeFrame: 5 days
measure: Delirium
timeFrame: 5 days
measure: Nauseas and Vomit
timeFrame: 5 days
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: hospital universitario San Vicente Fundacion
state: Antioquia
city: Medellín
country: Colombia
facility: Adriana Cadavid, MD
state: Antiquia
Study officials:
References: