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Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Sponsor
Hospital de Base (Other)
Overall Status
Unknown status
CT.gov ID
NCT03965442
Collaborator
(none)
66
Enrollment
1
Location
6.9
Anticipated Duration (Months)
9.5
Patients Per Site Per Month

Study Details

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 Phase

Study Design

Study Type:
Observational
Anticipated 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 :
Jan 1, 2019
Anticipated Primary Completion Date :
Jul 31, 2019
Anticipated Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm 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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hospital de Base do Distrito Federal Brasilia DF Brazil 70680250

Sponsors and Collaborators

  • Hospital de Base

Investigators

  • Principal Investigator: Fabricio T Mendonça, MD, Hospital de Base do Distrito Federal

Study Documents (Full-Text)

None provided.

More Information

Publications

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
Last Update Posted:
May 29, 2019
Last Verified:
May 1, 2019
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, Preceptor correspondent for anesthesiology residency, Hospital de Base
Post-mastectomy Pain Syndrome
Esmolol
Perioperative
Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Esmolol

Study Results

No Results Posted as of May 29, 2019