Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

• Conditions: Post-mastectomy Pain Syndrome
• Interventions: Drug: Control; Drug: Esmolol

• Registration Number: NCT03965442
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-02-21
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Study First Posted: 2019-05-29
• Last Update Posted: 2019-05-29
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	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.
Esmolol	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
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.

Trial Locations

Locations (1)

Hospital de Base do Distrito Federal; 🇧🇷 Brasilia, DF, Brazil