| Condition or disease | Intervention/treatment |
|---|---|
| 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 |
|---|---|
|
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
|
|
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
Patients who underwent mastectomy under general anesthesia with esmolol infusion
|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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.
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures |
|
||||||
| 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 |
||||||
| 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 |
|
||||||
| Study Groups/Cohorts |
|
||||||
| 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. |
|||||||
| 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:
|
||||||
| Sex/Gender |
|
||||||
| 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 |
|
||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Fabricio Tavares Mendonca, Hospital de Base | ||||||
| Study Sponsor | Hospital de Base | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
|
||||||
| PRS Account | Hospital de Base | ||||||
| Verification Date | May 2019 | ||||||