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Completed

NCT Number: NCT04286971

Preoperative Continuous Sciatic Perineural Analgesia in Patients Undergoing Lower Limb Revascularization

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Rafael M Linhares

Rio de Janeiro, 22776050, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Hospital Municipal Miguel Couto

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
May 19, 2020

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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