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Ischemic LegNCT04286971

Preoperative Continuous Sciatic Perineural Analgesia in Patients Undergoing Lower Limb Revascularization

An observational study of Ischemic Leg and Peripheral Vascular Disease, run by Hospital Municipal Miguel Couto at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Ischemic Leg, Peripheral Vascular Disease
How many people
15 participants
Where
1 siteBrazil
Study dates
19 Feb 2020to 30 Apr 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Rafael M Linhares

    Rio de Janeiro, 22776050

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Keywords
continuous peripheral block, sciatic block, ischemic pain
Medical subject headings
Peripheral Vascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in numerical pain scale

    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)

    Measured: 24 hours after placement of sciatic catheter

Secondary outcomes (3)

  1. change in numerical pain scale

    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)

    Measured: 72 hours after placement of sciatic catheter

  2. classification of technique difficulties

    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)

    Measured: 72 hours after placement of sciatic catheter

  3. classifications of possible complications

    Report, qualitatively, the presence of possible complications, such as: hyperemia of the catheter insertion site (HC); the presence of pus (PUS); catheter displacement (CD)

    Measured: 72 hours after placement of sciatic catheter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2020
  2. Study start19 Feb 2020
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04286971
Sponsor's protocol ID
25206319.3.0000.5279
Status last verified
May 2020
First submitted
25 Feb 2020
Last updated
19 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luiten WE, Schepers T, Luitse JS, Goslings JC, Hermanides J, Stevens MF, Hollmann MW, van Samkar G. Comparison of continuous nerve block versus patient-controlled analgesia for postoperative pain and outcome after talar and calcaneal fractures. Foot Ankle Int. 2014 Nov;35(11):1116-21. doi: 10.1177/1071100714546640. Epub 2014 Aug 12.

    PubMed 25116132

  • Thomas K, Barrett B, Tupper R, Dacenko-Grawe L, Holm K. Pain management after total knee arthroplasty: a case-control study of continuous nerve block therapy. Orthop Nurs. 2014 Sep-Oct;33(5):268-76. doi: 10.1097/NOR.0b013e3182879bd9.

    PubMed 25362748

  • Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.

    PubMed 21377070

  • Compere V, Cornet C, Fourdrinier V, Maitre AM, Duparc F, Biga N, Dureuil B. [Evaluation of continuous nerve block for postoperative pain management in orthopaedic surgery]. Ann Fr Anesth Reanim. 2005 Jul;24(7):795-801. doi: 10.1016/j.annfar.2005.04.025. French.

    PubMed 15949910

  • Aubuchon A, Arnold WD, Bracewell A, Hoyle JC. Sciatic neuropathy due to popliteal fossa nerve block. Muscle Nerve. 2017 Oct;56(4):822-824. doi: 10.1002/mus.25622. Epub 2017 Jun 6.

    PubMed 28214338

  • Dingemans SA, de Ruiter KJ, Birnie MFN, Goslings JC, van Samkar G, Schepers T. Comparable Postoperative Pain Levels Using 2 Different Nerve Blocks in the Operative Treatment of Displaced Intra-articular Calcaneal Fractures. Foot Ankle Int. 2017 Dec;38(12):1352-1356. doi: 10.1177/1071100717730337. Epub 2017 Sep 16.

    PubMed 28918661

  • Kim NY, Lee KY, Bai SJ, Hong JH, Lee J, Park JM, Kim SH. Comparison of the effects of remifentanil-based general anesthesia and popliteal nerve block on postoperative pain and hemodynamic stability in diabetic patients undergoing distal foot amputation: A retrospective observational study. Medicine (Baltimore). 2016 Jul;95(29):e4302. doi: 10.1097/MD.0000000000004302.

    PubMed 27442676

  • Dao T, Amaro-Driedger D, Mehta J. Successful treatment of Raynaud's syndrome in a lupus patient with continuous bilateral popliteal sciatic nerve blocks: a case report. Local Reg Anesth. 2016 Jun 15;9:35-7. doi: 10.2147/LRA.S97111. eCollection 2016.

    PubMed 27366104

  • Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20.

    PubMed 27871587

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Leg and Peripheral Vascular Disease, run by Hospital Municipal Miguel Couto at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in numerical pain scale (time frame: 24 hours after placement of sciatic catheter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04286971, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.

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