Condition or disease | Intervention/treatment |
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Post-mastectomy Pain Syndrome | Drug: Control Drug: Esmolol |
Study Type : | Observational |
Estimated Enrollment : | 66 participants |
Observational Model: | Case-Crossover |
Time Perspective: | Cross-Sectional |
Official Title: | Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | July 31, 2019 |
Estimated Study Completion Date : | July 31, 2019 |
Group/Cohort | Intervention/treatment |
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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
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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
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Drug: Esmolol
Patients who underwent mastectomy under general anesthesia with esmolol infusion
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial
Exclusion Criteria:
Contact: Fabricio T Mendonça, MD | +5561981882640 | correidofabricio@gmail.com |
Brazil | |
Hospital de Base do Distrito Federal | Recruiting |
Brasilia, DF, Brazil, 70680250 | |
Contact: Jamil Elias, MD 556133151588 uamphbdf@gmail.com | |
Contact: Viviane Rezende, MD 556133151331 vrezende@icab.med.br |
Principal Investigator: | Fabricio T Mendonça, MD | Hospital de Base do Distrito Federal |
Tracking Information | |||||||
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First Submitted Date | February 21, 2019 | ||||||
First Posted Date | May 29, 2019 | ||||||
Last Update Posted Date | May 29, 2019 | ||||||
Actual Study Start Date | January 1, 2019 | ||||||
Estimated Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Incidence of post-mastectomy chronic pain syndrome [ Time Frame: Through study completion, an average of 6 to 9 month ] Incidence analysis using a questionnaire applied to patients in the late postoperative period.
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Original Primary Outcome Measures | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome | ||||||
Official Title | Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study | ||||||
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 Provided | ||||||
Study Type | Observational | ||||||
Study Design | Observational Model: Case-Crossover Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
Condition | Post-mastectomy Pain Syndrome | ||||||
Intervention |
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Study Groups/Cohorts |
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Unknown status | ||||||
Estimated Enrollment |
66 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | July 31, 2019 | ||||||
Estimated Primary Completion Date | July 31, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria: - Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Brazil | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03965442 | ||||||
Other Study ID Numbers | Post-mastectomy pain | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Fabricio Tavares Mendonca, Hospital de Base | ||||||
Study Sponsor | Hospital de Base | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Hospital de Base | ||||||
Verification Date | May 2019 |