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Completed

NCT Number: NCT04278014

Continuous Sciatic Block Nerve in the Management of Vascular Pain in Critical Ischemia of Lower Limbs Patients

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

hospital universitario San Vicente Fundacion, Medellín, Antioquia, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound-guided continuous sciatic block with longitudinal approach

Procedure

ultrasound-guided continuous sciatic block with longitudinal approach

Primary outcomes

  1. 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

Secondary outcomes

  1. Pinprick test

    Time frame: 5 days

    evaluation of superficial sensitivity in S1 dermatome positive or negative

  2. catheter duration

    Time frame: 5 days

    number of days in which the catheter is functional

  3. opioid consumption reduction

    Time frame: 5 days

    opioid consumption in morphine equivalence

  4. Delirium

    Time frame: 5 days

    minimental test score from 0 to 30 points. Delirium positive for less than 24

  5. Nauseas and Vomit

    Time frame: 5 days

    yes or not present

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2020
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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