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

Completed

• Conditions: Critical Limb Ischemia

• Registration Number: NCT04278014
• Lead Sponsor: Universidad de Antioquia

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.

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-06-01
• Status Verified: 2021-02
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain level measurement with Numeric Rate Score (NRS)	5 days	0-10 where 0 means no pain and 10 means maximum possible pain

Secondary Outcome Measures

Name	Time	Method
Pinprick test	5 days	evaluation of superficial sensitivity in S1 dermatome positive or negative
catheter duration	5 days	number of days in which the catheter is functional
opioid consumption reduction	5 days	opioid consumption in morphine equivalence
Delirium	5 days	minimental test score from 0 to 30 points. Delirium positive for less than 24
Nauseas and Vomit	5 days	yes or not present

Trial Locations

Locations (2)

hospital universitario San Vicente Fundacion; 🇨🇴 Medellin, Antioquia, Colombia

Adriana Cadavid, MD; 🇨🇴 Medellín, Antiquia, Colombia