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

NCT04676438 | Completed

• 1 other identifier: PPMP_INO
• Study Type: observational
• Target: 722
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasms; Pain, Postoperative; Pain, Chronic

Keywords

Breast Neoplasms; Pain, Postoperative; Mastectomy and pain syndrome

Outcome Measures

Primary Outcomes (1)

• Post-mastectomy pain

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

  preoperative-3months postoperative

Study Arms (1)

Patients receiving surgery breast surgery for cancer at National Institute of Oncology

No intervention will be administered

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergo breast surgery at National Institute of Oncology (Sheikha Fatma center)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Moroccan Society of Surgery: lead

Study Sites (2)

National Institute of Oncology of Rabat

Rabat, 10170, Morocco

Location

National Institut of Oncology, Surgical oncology department

Rabat, Morocco

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain; Somatoform Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdelilah Ghannam, MD

  Mohammed V University in Rabat

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 10, 2018
• Primary Completion: September 8, 2020
• Study Completion: March 7, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

MO (2)