Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

NCT ID: NCT03965442

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-07-31

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.

Conditions

Post-mastectomy Pain Syndrome

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Control

Intervention Type: DRUG

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

Esmolol

Intervention Type: DRUG

Patients who underwent mastectomy under general anesthesia with esmolol infusion

Interventions

Control

Patients who underwent mastectomy under standard general anesthesia

Intervention Type: DRUG

Esmolol

Patients who underwent mastectomy under general anesthesia with esmolol infusion

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Base

OTHER

Sponsor Role: lead

Responsible Party

Fabricio Tavares Mendonca

Preceptor correspondent for anesthesiology residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabricio T Mendonça, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base do Distrito Federal

Locations

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fabricio T Mendonça, MD

Role: CONTACT

correidofabricio@gmail.com

+5561981882640

Facility Contacts

Jamil Elias, MD

Role: primary

uamphbdf@gmail.com

556133151588

Viviane Rezende, MD

Role: backup

vrezende@icab.med.br

556133151331

References

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.

Reference Type: BACKGROUND

PMID: 19903919 (View on PubMed)

Other Identifiers

Post-mastectomy pain

Identifier Type: -

Identifier Source: org_study_id