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Prevalence, Impact and Predictors of Chronic Postoperative Pain

Evaluation of the Prevalence and Impact of Chronic Postoperative Pain and Risk Factor Analysis: a Multi-center Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03363672
Enrollment
500
Registered
2017-12-06
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Postoperative Pain

Keywords

Chronic Postoperative Pain, Daily Life, Risk Factor

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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients receiving surgery under general anesthesia during 2018 in Peking Union Medical College Hospital and other medical centers participating in this study. * Aged 18-70 years.

Exclusion criteria

* Previous surgery history; * Preoperative chronic pain history; * Injury; * Have no access to mobile phone or website; * Postoperative chronic infection; * Non-radical incision of tumor or malignancy recurrence during follow-up;

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of chronic postoperative pain24 weeks postoperativelyThe prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app

Secondary

MeasureTime frameDescription
The prevalence of chronic postoperative pain4,8,12,16,20,32,40,48 weeks postoperativelyThe prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app
Wong-Baker Faces Pain Rating Scale4,8,12,16,20,24,32,40,48 weeks postoperativelyThe intensity of CPP will be evaluated by Wong-Baker FACES Pain Rating. The scale shows a series of faces ranging from a happy face at 0 which represents no hurt to a crying face at 10 which represents hurts worst. Scale.
Characteristics and location of chronic postoperative pain4,8,12,16,20,24,32,40,48 weeks postoperativelyThe common characteristics and location of CPP will also be summarized according to the patients' choice in survey.
Brief Pain Index4,8,12,16,20,24,32,40,48 weeks postoperativelyBrief Pain Index will be used to assess the impact of chronic postoperative pain on daily life.

Contacts

Primary ContactYuguang Huang, MD.
garypumch@163.com86-10-69152066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026