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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

Tracking Information
First Submitted Date  ICMJE July 17, 2016
First Posted Date  ICMJE July 22, 2016
Last Update Posted Date July 22, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Pain intensity [ Time Frame: up to 28th day ]
Verbal numerical scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2016)
Opioids Adverse effects [ Time Frame: up to 28th day ]
Nausea, vomiting, constipation, sedation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ischemic Pain Control With Analgesic Methods Clinical Trial
Official Title  ICMJE Comparative Study Between Systemic Analgesia and Continuous Sciatic Nerve Block in Patients With Chronic Obstructive Arterial Disease and Ischemic Pain in Lower Limbs
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arterial Occlusive Diseases
Intervention  ICMJE
  • Procedure: Continuous peripheral sciatic nerve block
    Continuous infusion of local anesthetics through perineural sciatic nerve catheter
    Other Name: Perineural sciatic catheter
  • Drug: Fentanyl
    Use of patient controlled analgesia device with intravenous fentanyl
    Other Name: Intravenous fentanyl
  • Drug: Ropivacaine
  • Device: Perineural catheter
Study Arms  ICMJE
  • Active Comparator: Continuous nerve block
    Continuous peripheral sciatic nerve block through popliteal perineural catheter with ropivacaine
    Interventions:
    • Procedure: Continuous peripheral sciatic nerve block
    • Drug: Ropivacaine
    • Device: Perineural catheter
  • Active Comparator: Systemic analgesia
    Intravenous fentanyl patient controlled analgesia device
    Intervention: Drug: Fentanyl
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 21, 2016)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02841488
Other Study ID Numbers  ICMJE CAAE: 55187516.4.0000.0068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hermann dos Santos Fernandes, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joaquim E Vieira, PhD Professor
PRS Account University of Sao Paulo General Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP