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Persistant Post-mastectomy Pain in Breast Cancer : Incidence and Risk Factors

Incidence and Risk Factors of Chronic (Persistant) Post-surgical Pain in Oncological Breast Surgery : a Prospective Cohort Study in a National Institute of Oncology

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04676438
Enrollment
722
Registered
2020-12-21
Start date
2018-12-10
Completion date
2021-03-07
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Pain, Chronic, Pain, Postoperative

Keywords

Breast Neoplasms, Pain, Postoperative, Mastectomy and pain syndrome

Brief summary

Post Mastectomy Pain Syndrome (PMPS) is a major complication of breast surgery responsible for depression and disability. The project consists of a prospective cohort on patients going for oncological breast surgery at National Institute of Oncology of Rabat. Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem, which could last for more than 3 months after surgery. The aim of present study was to assess the prevalence of CPP, investigate its impact on life quality and explore its potential risk factors. After informed consent was signed, patients receiving surgery under general anesthesia in Peking Union Medical College Hospital and other medical centers participating in this study during 2018 will be included. Patients' preoperative information will be collected from medical record, including basic demographic data, primary disease and previous chronic diseases. Intraoperative information will be obtained from anesthesia record, including surgical scope, duration, length and location of incisions and blood loss. Acute pain will be evaluated in the ward of the department of surgery, when an app will be installed on patients' mobile phones. Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th, 8th, 16th, 32th, and 48th weeks after surgery. The survey covers questions regarding the intensity, characteristic, location and impact on daily activities of CPP. Information regarding treatment of CPP will also be collected, if any. All the data gained will be summarized in our database and analyzed.

Detailed description

Type of work: This is an observational, prospective, open, data-driven, single-center study at the National Institute of Oncology (NIO) - Mohamed Ben Abdellah Hospital in Rabat, affiliated to Mohammed V University in Rabat. The objective of the study we are proposing is to determine the incidence and risk factors of chronic post-surgical pain in oncological breast surgery on the Moroccan population operated on and followed at the Sheikha Fatma Center of the National Institute of 'Oncology of Rabat. The main objective of the study is to: \- Determine the incidence of chronic post-surgical pain in carcinological breast surgery The secondary objectives are: * Determine the clinical characteristics of chronic post-surgical pain and in particular the proportion of neuropathic pain and / or post-mastectomy pain syndromes * Identify the preoperative, intraoperative and postoperative risk factors of developing chronic post-surgical pain in the Moroccan population * Determine the incidence of acute severe postoperative pain * Determine the characteristics of acute postoperative pain * Identify the risk factors for severe acute postoperative pain Work flow: * The medical care of patients will be free to the responsible practitioners, according to the usual practice * Nursing staff will be informed of the study * An investigator will be appointed after training in the protocol. He will be independent and not responsible for the nursing activity * Patients eligible for the study will be identified during the pre-anesthetic consultation, carried out in the week before surgery * The recorded agreements will be obtained during these consultations * Patients will be included once admitted to the operating room and operated * The data collected is presented in the observation book in the appendix with the definitions of the events and the entry rules * The patients will be followed up and reviewed at 3 months and 6 months in surgery consultation for reassessment and completion of the observation book

Interventions

None listed

Sponsors

Moroccan Society of Surgery
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Willingness and ability to sign an informed consent document * More than 18 years of age * All American Society of Anesthesiology classes * Patient undergo for breast surgery

Exclusion criteria

* Patients who expressed their refusal to participate in the study * Patients unable to express their non-opposition to participating in the study

Design outcomes

Primary

MeasureTime frameDescription
Post-mastectomy painpreoperative-3months postoperativeAssessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment

Countries

Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026