Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

NCT03965442 | Unknown FDA Drug

• 1 other identifier: Post-mastectomy pain
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

Post-mastectomy Pain Syndrome; Esmolol; Perioperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assess the intensity of pain: Pain Scores on the Visual Analog Scale

  Through study completion, an average of 6 to 9 month

• Identify possible risk factors

  Through study completion, an average of 6 to 9 month

• Stratify the possible types of pain

  Through study completion, an average of 6 to 9 month

Study Arms (2)

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

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

Interventions

Control DRUG

Patients who underwent mastectomy under standard general anesthesia

Control

Esmolol DRUG

Patients who underwent mastectomy under general anesthesia with esmolol infusion

Esmolol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 19903919 BACKGROUND

MeSH Terms

Interventions

esmolol

Study Officials

• Fabricio T Mendonça, MD

  Hospital de Base do Distrito Federal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio T Mendonça, MD

CONTACT

+5561981882640; correidofabricio@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Preceptor correspondent for anesthesiology residency

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: May 29, 2019
• Study Start: January 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

BR (1)