Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study

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.

Study Overview

• Status: Unknown
• Conditions: Post-mastectomy Pain Syndrome
• Intervention / Treatment: Drug: Control; Drug: Esmolol

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

Study Locations

• Brazil
  • DF
    • Brasilia, DF, Brazil, 70680250
      • Recruiting
      • Hospital de Base do Distrito Federal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the intensity of pain: Pain Scores on the Visual Analog Scale	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	Through study completion, an average of 6 to 9 month
Identify possible risk factors	Incidence analysis using a questionnaire applied to patients in the late postoperative period.	Through study completion, an average of 6 to 9 month
Stratify the possible types of pain	Application of a questionnaire to identify the characteristics of pain (Neuropatic or non-neuropatic pain)	Through study completion, an average of 6 to 9 month

Collaborators and Investigators

• Sponsor: Hospital de Base

Publications and helpful links

General Publications

• Gartner 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ANTICIPATED): July 31, 2019
• Study Completion (ANTICIPATED): July 31, 2019

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Perioperative; Esmolol; Post-mastectomy Pain Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Syndrome; Somatoform Disorders; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-1 Receptor Antagonists; Esmolol
• Other Study ID Numbers: Post-mastectomy pain

Drug and device information, study documents

• 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