NCT04278014

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 5, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 18, 2020

Last Update Submit

April 30, 2021

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

  • Pain level measurement with Numeric Rate Score (NRS)

    0-10 where 0 means no pain and 10 means maximum possible pain

    5 days

Secondary Outcomes (5)

  • Pinprick test

    5 days

  • catheter duration

    5 days

  • opioid consumption reduction

    5 days

  • Delirium

    5 days

  • Nauseas and Vomit

    5 days

Interventions

ultrasound-guided continuous sciatic block with longitudinal approachPROCEDURE

ultrasound-guided continuous sciatic block with longitudinal approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with a diagnosis of critical ischemia of the lower limb with severe pain and side effects of opioids

You may not qualify if:

  • Under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

hospital universitario San Vicente Fundacion

Medellín, Antioquia, 0057, Colombia

Location

Adriana Cadavid, MD

Medellín, Antiquia, 050010, Colombia

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

June 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

May 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CO(2)