Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
500

Summary

Conditions
  • Breast Neoplasms
  • Pain, Chronic
  • Pain Postoperative
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 an...

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

Tracking Information

NCT #
NCT04676438
Collaborators
Not Provided
Investigators
Principal Investigator: Abdelilah Ghannam, MD Mohammed V University in Rabat