NCT04286971

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 19, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

February 25, 2020

Last Update Submit

May 15, 2020

Conditions

Keywords

continuous peripheral blocksciatic blockischemic pain

Outcome Measures

Primary Outcomes (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)

    24 hours after placement of sciatic catheter

Secondary Outcomes (3)

  • change in numerical pain scale

    72 hours after placement of sciatic catheter

  • classification of technique difficulties

    72 hours after placement of sciatic catheter

  • classifications of possible complications

    72 hours after placement of sciatic catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rafael M Linhares

Rio de Janeiro, 22776050, Brazil

Location

Related Publications (9)

  • 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.

    PMID: 25116132BACKGROUND
  • 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.

    PMID: 25362748BACKGROUND
  • 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.

    PMID: 21377070BACKGROUND
  • 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.

    PMID: 15949910BACKGROUND
  • 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.

    PMID: 28214338BACKGROUND
  • 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.

    PMID: 28918661BACKGROUND
  • 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.

    PMID: 27442676BACKGROUND
  • 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.

    PMID: 27366104BACKGROUND
  • 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.

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology and Pain Medicine Department

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

February 19, 2020

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations