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Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965442
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Fabricio Tavares Mendonca, Hospital de Base

Brief Summary:
Chronic postoperative pain is an entity that is usually neglected by anesthetists, but several studies show that the choice of anesthetic technique may interfere with this prevalence. Esmolol is a selective beta-blocker of ultra fast duration that has been studied as a perioperative venous adjuvant with antihyperalgesic and opioid sparing action. The investigators ventured the possibility of this anti-hyperalgesic effect attenuating the chronic pain syndrome post-mastectomy.

Condition or disease Intervention/treatment
Post-mastectomy Pain Syndrome Drug: Control Drug: Esmolol

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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019


Group/Cohort Intervention/treatment
Control

Patients who underwent mastectomy under standard general anesthesia

Patients in placebo group received general balanced inhaled anesthesia with sevoflurane and remifentanil and a saline 0,9% infusion pump.

Drug: Control
Patients who underwent mastectomy under standard general anesthesia

Esmolol
Patients in esmolol group received general balanced inhaled anesthesia with sevoflurane and a bolus infection of esmolol 500 mgc/kg followed by a continuous infusion of esmolol 100 mcg/kg/min
Drug: Esmolol
Patients who underwent mastectomy under general anesthesia with esmolol infusion




Primary Outcome Measures :
  1. Incidence of post-mastectomy chronic pain syndrome [ Time Frame: Through study completion, an average of 6 to 9 month ]
    Incidence analysis using a questionnaire applied to patients in the late postoperative period.


Secondary Outcome Measures :
  1. Assess the intensity of pain: Pain Scores on the Visual Analog Scale [ Time Frame: Through study completion, an average of 6 to 9 month ]
    Pain Scores on the Visual Analog Scale, from zero to 10: 0 being represented by absence of pain and 10 being the worst possible pain

  2. Identify possible risk factors [ Time Frame: Through study completion, an average of 6 to 9 month ]
    Incidence analysis using a questionnaire applied to patients in the late postoperative period.

  3. Stratify the possible types of pain [ Time Frame: Through study completion, an average of 6 to 9 month ]
    Application of a questionnaire to identify the characteristics of pain (Neuropatic or non-neuropatic pain)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial, will be submitted to a questionnaire of adapted from DNS4.
Criteria

Inclusion Criteria:

- Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial

Exclusion Criteria:

  • Patient aged less than 18 years and over 65 years;
  • Patients who refuse to participate in the study;
  • Patients with pulmonary disease;
  • Patients with cardiac, renal or hepatic disease;
  • Use of psychoactive drug;
  • Patients with sinus bradycardia;
  • Pregnant women;
  • Patients with allergy to dipyrone, morphine;
  • Patients with chronic pain prior to the surgical procedure;
  • Patients with neurological disorders;
  • Patients undergoing surgical resurfacing

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): NCT03965442


Contacts
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Contact: Fabricio T Mendonça, MD +5561981882640 correidofabricio@gmail.com

Locations
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Brazil
Hospital de Base do Distrito Federal Recruiting
Brasilia, DF, Brazil, 70680250
Contact: Jamil Elias, MD    556133151588    uamphbdf@gmail.com   
Contact: Viviane Rezende, MD    556133151331    vrezende@icab.med.br   
Sponsors and Collaborators
Hospital de Base
Investigators
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Principal Investigator: Fabricio T Mendonça, MD Hospital de Base do Distrito Federal
Publications:
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Responsible Party: Fabricio Tavares Mendonca, Preceptor correspondent for anesthesiology residency, Hospital de Base
ClinicalTrials.gov Identifier: NCT03965442    
Other Study ID Numbers: Post-mastectomy pain
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fabricio Tavares Mendonca, Hospital de Base:
Post-mastectomy Pain Syndrome
Esmolol
Perioperative
Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Esmolol
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs