Prevalence, Impact and Predictors of Chronic Postoperative Pain

Chronic Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03363672
• Other study ID #: PUMCH-CPP
• Status: Not yet recruiting
• Phase: N/A
• First received: November 20, 2017
• Last updated: November 30, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: Peking Union Medical College Hospital
• Contact: Yuguang Huang, MD.
• Phone: 86-10-69152066
• Email: garypumch[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of chronic postoperative pain	The prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app	24 weeks postoperatively
Secondary	The prevalence of chronic postoperative pain	The prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app	4,8,12,16,20,32,40,48 weeks postoperatively
Secondary	Wong-Baker Faces Pain Rating Scale	The 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.	4,8,12,16,20,24,32,40,48 weeks postoperatively
Secondary	Characteristics and location of chronic postoperative pain	The common characteristics and location of CPP will also be summarized according to the patients' choice in survey.	4,8,12,16,20,24,32,40,48 weeks postoperatively
Secondary	Brief Pain Index	Brief Pain Index will be used to assess the impact of chronic postoperative pain on daily life.	4,8,12,16,20,24,32,40,48 weeks postoperatively