Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03363672
Status:
UNKNOWN
Last Update Posted:
2017-12-06
First Post:
2017-11-20
Brief Title:
Prevalence Impact and Predictors of Chronic Postoperative Pain
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Evaluation of the Prevalence and Impact of Chronic Postoperative Pain and Risk Factor Analysis a Multi-center Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
Chronic postoperative pain CPP remains a disturbing and obscure clinical problem which could persist beyond wound healing phase and last for more than 3 months after surgery The prevalence of CPP after sternotomy is estimated to be as high as 14-61 according to several recent studies However CPP following other types of surgeries has not been well evaluated There is paucity of literature regarding the impact of CPP on daily life as well Additionally the identification of predisposing factors for CPP would provide clues for its prevention and treatment 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 during 2018 will be included The sample size in Peking Union Medical College Hospital is estimated to be approximately 700 Furthermore we are trying to contact with other large hospitals in China to make a multi-center study
Patients preoperative information will be collected from medical record including basic demographic data primary disease tumor size location and peripheral invasion and previous chronic diseases hypertension diabetes coronary heart disease chronic kidney disease anxiety and depression Intraoperative information will be obtained from anesthesia record including surgical scope duration length and location of incisions and blood loss Postoperative pain control methods can be learned from medical orders Acute pain will be evaluated in the ward of the department of surgery before discharge At the same time 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 Wong-Baker FACES Pain Rating Scale characteristic location and impact on daily activities Brief Pain Index BPI of CPP Furthermore information regarding treatment of CPP will also be collected if any All the data obtained from app could be included into our database and statistically analyzed
After informed consent was signed patients receiving surgery under general anesthesia during 2018 will be included The sample size in Peking Union Medical College Hospital is estimated to be approximately 700 Furthermore we are trying to contact with other large hospitals in China to make a multi-center study
Patients preoperative information will be collected from medical record including basic demographic data primary disease tumor size location and peripheral invasion and previous chronic diseases hypertension diabetes coronary heart disease chronic kidney disease anxiety and depression Intraoperative information will be obtained from anesthesia record including surgical scope duration length and location of incisions and blood loss Postoperative pain control methods can be learned from medical orders Acute pain will be evaluated in the ward of the department of surgery before discharge At the same time 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 Wong-Baker FACES Pain Rating Scale characteristic location and impact on daily activities Brief Pain Index BPI of CPP Furthermore information regarding treatment of CPP will also be collected if any All the data obtained from app could be included into our database and statistically analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None