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出境医 / 临床实验 / Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Study Description
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

Study Design
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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
Arms and Interventions
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

Outcome Measures
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)


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date February 21, 2019
First Posted Date May 29, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 28, 2019)
  • 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
  • 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.
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome
Official Title Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Post-mastectomy Pain Syndrome
Intervention
  • Drug: Control
    Patients who underwent mastectomy under standard general anesthesia
  • Drug: Esmolol
    Patients who underwent mastectomy under general anesthesia with esmolol infusion
Study Groups/Cohorts
  • 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.

    Intervention: Drug: Control
  • 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
    Intervention: Drug: Esmolol
Publications * Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 28, 2019)
66
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT03965442
Other Study ID Numbers Post-mastectomy pain
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Fabricio Tavares Mendonca, Hospital de Base
Study Sponsor Hospital de Base
Collaborators Not Provided
Investigators
Principal Investigator: Fabricio T Mendonça, MD Hospital de Base do Distrito Federal
PRS Account Hospital de Base
Verification Date May 2019

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