Preoperative Continuous Sciatic Perineural Analgesia in Patients Undergoing Lower Limb Revascularization

May 15, 2020 updated by: Rafael Mercante Linhares, Hospital Municipal Miguel Couto

Preoperative Continuous Sciatic Perineural Analgesia, as a Bridge Therapy for Ischemic Pain, in Patients Undergoing Lower Limb Revascularization: a Retrospective Descriptive Study

This study evaluates the pain score numerical rating, after sciatic analgesic continuous block, in patients with ischemic pain before surgery of limb revascularization. All patients received those blocks to control ischemic severe pain.

Study Overview

Status

Completed

Conditions

Detailed Description

Peripheral Obstructive Arterial Disease (PAD) is a disease with a prevalence of 10 to 25% in the population over 55 years, increasing with age, and may have disabling pain as a symptom, and sometimes the surgical approach is required. In the context of public hospital in Rio de Janeiro, where patients need to wait for surgery, the Anesthesiology and Acute Pain service routinely has sciatic nerve analgesic block in the popliteal region as a preoperative procedure.

The primary objective of the present study is to describe a series of cases where the technique was applied in order to relieve the pain of these patients, following the Pain Score Numerical rating as a reference. Secondary objectives will be to describe difficulties associated with the technique and possible associated adverse factors.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22776050
        • Rafael M Linhares

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with lower limb isquemic pain caused by peripheral arterial disease in the preoperative period.

Description

Inclusion Criteria:

  • preoperative continuous sciatic-popliteal nerve block
  • lower limb angioplasty
  • peripheral arterial disease;
  • between 2017 and 2018 years;
  • correct filling of numerical rating pain evaluation in the medical record

Exclusion Criteria:

  • peripheral block to treat another pathology or condition in te same patient;
  • peripheral block at another concomitant site (other than the popliteal);
  • No adequate record of the care received in the medical record
  • if medical record is not available during the data collection period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in numerical pain scale
Time Frame: 24 hours after placement of sciatic catheter
Numerical Pain Scale (END) self-assessed by the patient before and after 24 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be)
24 hours after placement of sciatic catheter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in numerical pain scale
Time Frame: 72 hours after placement of sciatic catheter
Numerical Pain Scale (END) self-assessed by the patient before and after 72 hours of continuous analgesic block of the sciatic nerve, with infusion of levobupivacaine 0,125% or ropivacaine 0,2%. The scale score is 0-10 (0= no pain; 10 = pain as bad as can be)
72 hours after placement of sciatic catheter
classification of technique difficulties
Time Frame: 72 hours after placement of sciatic catheter
To report, qualitatively, the presence of variations or difficulties in the use of the technique, such as: failure of the technique (FT); existence of concomitant venous analgesia (VA); inadequate registration of the technique (IR)
72 hours after placement of sciatic catheter
classifications of possible complications
Time Frame: 72 hours after placement of sciatic catheter
Report, qualitatively, the presence of possible complications, such as: hyperemia of the catheter insertion site (HC); the presence of pus (PUS); catheter displacement (CD)
72 hours after placement of sciatic catheter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Municipal Miguel Couto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25206319.3.0000.5279

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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