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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Chronic Pain Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Chronic Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Somatoform Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Institut of Oncology, Surgical oncology department, Rabat, Morocco

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Post-mastectomy pain

Time frame: preoperative-3months postoperative

Assessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment

Sponsors and collaborators

Lead sponsor

Moroccan Society of Surgery

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Dec 21, 2020
Registry last updated: Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed