Clinical trial NCT04676438: Persistant Post-mastectomy Pain in Breast Cancer : Incidence and Risk Factors
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Pain, Postoperative
Pain, Chronic
Keywords: Breast Neoplasms
Pain, Postoperative
Mastectomy and pain syndrome
Lead sponsor: Moroccan Society of Surgery
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 722
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergo breast surgery at National Institute of Oncology (Sheikha Fatma center)

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

Eligibility criteria: 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

Primary outcomes:
measure: Post-mastectomy pain
timeFrame: preoperative-3months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: National Institute of Oncology of Rabat
city: Rabat
country: Morocco
facility: National Institut of Oncology, Surgical oncology department
Study officials:
affiliation: Mohammed V University in Rabat
name: Abdelilah Ghannam, MD
role: PRINCIPAL_INVESTIGATOR
References: