Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Post-mastectomy Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965442
• Other study ID #: Post-mastectomy pain
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: May 2019
• Source: Hospital de Base
• Contact: Fabricio T Mendonça, MD
• Phone: +5561981882640
• Email: correidofabricio[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-mastectomy Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Control
Patients who underwent mastectomy under standard general anesthesia
• Esmolol
Patients who underwent mastectomy under general anesthesia with esmolol infusion

Locations

Country	Name	City	State
Brazil	Hospital de Base do Distrito Federal	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Base

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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