Post-mastectomy Pain SyndromeNCT03965442
Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome
An observational study of Post-mastectomy Pain Syndrome, run by Hospital de Base at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-mastectomy Pain Syndrome
- What is being tested?
- Esmolol
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Base do Distrito Federal
Brasília, Federal District, 70680250
Jamil Elias, MD, 556133151588, uamphbdf@gmail.com
Viviane Rezende, MD, 556133151331, vrezende@icab.med.br
About this study
Official title: Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study
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
- Being tested
- Control, Esmolol
- Keywords
- Post-mastectomy Pain Syndrome, Esmolol, Perioperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDrug
Patients who underwent mastectomy under standard general anesthesia
EsmololDrug
Patients who underwent mastectomy under general anesthesia with esmolol infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Esmolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-mastectomy chronic pain syndrome
Incidence analysis using a questionnaire applied to patients in the late postoperative period.
Measured: 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
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
Measured: Through study completion, an average of 6 to 9 month
Identify possible risk factors
Incidence analysis using a questionnaire applied to patients in the late postoperative period.
Measured: Through study completion, an average of 6 to 9 month
Stratify the possible types of pain
Application of a questionnaire to identify the characteristics of pain (Neuropatic or non-neuropatic pain)
Measured: Through study completion, an average of 6 to 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2019
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-mastectomy Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Tavares Mendonca, Hospital de Base
- Investigators
- Fabricio T Mendonça, MD, Principal investigator, Hospital de Base do Distrito Federal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965442
- Sponsor's protocol ID
- Post-mastectomy pain
- Status last verified
- May 2019
- First submitted
- 21 Feb 2019
- Last updated
- 29 May 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 19903919
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03965442
- Acronym / sponsor ID
- Post-mastectomy pain
- Conditions
- Post-mastectomy Pain Syndrome
- Keywords
- Post-mastectomy Pain Syndrome, Esmolol, Perioperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Drug: ControlPatients 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. |
| Esmolol | – | Drug: EsmololPatients 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlPatients who underwent mastectomy under standard general anesthesia | Drug | Control |
| EsmololPatients who underwent mastectomy under general anesthesia with esmolol infusion | Drug | Esmolol |
Primary outcome
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.
3 secondary outcomes
Assess the intensity of pain: Pain Scores on the Visual Analog Scale
Time frame: Through study completion, an average of 6 to 9 month
Identify possible risk factors
Time frame: Through study completion, an average of 6 to 9 month
Stratify the possible types of pain
Time frame: Through study completion, an average of 6 to 9 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Background: PubMed 19903919Gartner 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.
Related trials for Post-mastectomy Pain Syndrome
Not yet recruiting
Regenerative Peripheral Nerve Interface for Prophylaxis Against Post-Breast Surgery Pain Syndrome
Post-mastectomy Pain Syndrome
Active, not recruitingPhase 3
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)
Post-mastectomy Pain Syndrome, Breast Cancer
Not yet recruiting
Super-voltage PRF of Stellate Ganglion Versus Super-voltage PRF of T2 T3 Sympathetic Ganglia in Managing PMPS.
Post Mastectomy Pain Syndrome, Chronic Pain Following Surgical Procedure for Cancer
RecruitingPhase 4
Dex & Mastectomy Pain
Post-Mastectomy Chronic Pain Syndrome
Not yet recruiting
Adding Magnesium Sulphate to Combined Pectointercostal Plane and Erector Spinae Plane Blocks for Acute and Chronic Post-Mastectomy Pain
Post-mastectomy Pain Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabricio T Mendonça, MD principal investigator
Hospital de Base do Distrito Federal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-mastectomy Pain Syndrome, run by Hospital de Base at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabricio T Mendonça, MD (+5561981882640, correidofabricio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-mastectomy chronic pain syndrome (time frame: Through study completion, an average of 6 to 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03965442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019.