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Ischemic Pain Control With Analgesic Methods Clinical Trial (ISCHAEMIC)

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ClinicalTrials.gov Identifier: NCT02841488
Recruitment Status : Unknown
Verified July 2016 by Hermann dos Santos Fernandes, University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Hermann dos Santos Fernandes, University of Sao Paulo General Hospital

Brief Summary:

This project is one of four components of a thematic project that aims to evaluate the use of ultrasound in regional blocks, called "Use of ultrasound in regional blocks and injections for the treatment of acute and chronic pain."

It will evaluate quantitative and qualitative control of ischemic pain in the lower limbs in patients with peripheral arterial occlusive disease through continuous sciatic nerve block by perineural catheter, popliteal approach, compared to systemic analgesia based on opioids.


Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Procedure: Continuous peripheral sciatic nerve block Drug: Fentanyl Drug: Ropivacaine Device: Perineural catheter Phase 3

Detailed Description:

BACKGROUND: Peripheral arterial occlusive disease (PAOD) commonly evolves with intense ischemic pain in the lower limbs, which is hard to control with systemic analgesics, and continuous regional anesthesia may be an alternative, with adequate analgesia and lower incidence of side effects.

OBJECTIVES: evaluate qualitative and quantitative pain control, incidence of adverse effects and operative results in patients with PAOD undergoing continuous anesthetic blockade of the sciatic nerve by perineural catheter compared to systemic analgesia based on opioids and adjuvant medications.

METHODS: It is a randomized clinical trial, covered for evaluators. It will include 56 patients with PAOD Fontaine IV, with pain by the presence of ulcerations located on foot. A group will be submitted to continuous regional anesthesia of sciatic nerve through perineural catheter and another group will have its pain control through patient controlled analgesia device with intravenous fentanyl. The primary dependent variable will be pain, through the numerical pain scale.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between Systemic Analgesia and Continuous Sciatic Nerve Block in Patients With Chronic Obstructive Arterial Disease and Ischemic Pain in Lower Limbs
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous nerve block
Continuous peripheral sciatic nerve block through popliteal perineural catheter with ropivacaine
Procedure: Continuous peripheral sciatic nerve block
Continuous infusion of local anesthetics through perineural sciatic nerve catheter
Other Name: Perineural sciatic catheter

Drug: Ropivacaine
Device: Perineural catheter
Active Comparator: Systemic analgesia
Intravenous fentanyl patient controlled analgesia device
Drug: Fentanyl
Use of patient controlled analgesia device with intravenous fentanyl
Other Name: Intravenous fentanyl




Primary Outcome Measures :
  1. Pain intensity [ Time Frame: up to 28th day ]
    Verbal numerical scale


Secondary Outcome Measures :
  1. Opioids Adverse effects [ Time Frame: up to 28th day ]
    Nausea, vomiting, constipation, sedation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years old who have strong or moderate persistent ischemic pain in the lower limbs, due to peripheral artery occlusive disease, classified as Fontaine IV (pain at rest and presence of ulcer or gangrene).

Exclusion Criteria:

  • Uncooperative patients, coagulation disorders, patients with liver failure, who have atrioventricular block second or third degree, who refuse to be submitted to peripheral nerve block, with systemic or procedure site local infection infection, peripheral or central neuropathy history, allergies to local anesthetics or to any of the drugs to be used in the study and difficulty in understanding the use of the PCA (patient-controlled analgesia) device and evaluation methods used in the study .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841488


Contacts
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Contact: Hermann S Fernandes, MD +55 84 988966348 hermann.fernandes@hc.fm.usp.br
Contact: Hazem A Ashmawi, PhD +55 11 985733798 hazem.ashmawi@hc.fm.usp.br

Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Joaquim E Vieira, PhD Professor
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Hermann dos Santos Fernandes, M.D., University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02841488    
Other Study ID Numbers: CAAE: 55187516.4.0000.0068
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Fentanyl
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local