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

Critical Limb Ischemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278014
• Other study ID #: UdeA1006
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Procedure:
• ultrasound-guided continuous sciatic block with longitudinal approach
ultrasound-guided continuous sciatic block with longitudinal approach

Locations

Country	Name	City	State
Colombia	hospital universitario San Vicente Fundacion	Medellin	Antioquia
Colombia	Adriana Cadavid, MD	Medellín	Antiquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level measurement with Numeric Rate Score (NRS)	0-10 where 0 means no pain and 10 means maximum possible pain	5 days
Secondary	Pinprick test	evaluation of superficial sensitivity in S1 dermatome positive or negative	5 days
Secondary	catheter duration	number of days in which the catheter is functional	5 days
Secondary	opioid consumption reduction	opioid consumption in morphine equivalence	5 days
Secondary	Delirium	minimental test score from 0 to 30 points. Delirium positive for less than 24	5 days
Secondary	Nauseas and Vomit	yes or not present	5 days