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Prevalence, Impact and Predictors of Chronic Postoperative Pain

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ClinicalTrials.gov Identifier: NCT03363672
Recruitment Status : Not yet recruiting
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Huang YuGuang, Peking Union Medical College Hospital

November 20, 2017
December 6, 2017
December 6, 2017
January 1, 2018
December 31, 2019   (Final data collection date for primary outcome measure)
The prevalence of chronic postoperative pain [ Time Frame: 24 weeks postoperatively ]
The prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app
Same as current
No Changes Posted
  • The prevalence of chronic postoperative pain [ Time Frame: 4,8,12,16,20,32,40,48 weeks postoperatively ]
    The prevalence of chronic postoperative pain reported by the included patients in the questionnaire issued by app
  • Wong-Baker Faces Pain Rating Scale [ Time Frame: 4,8,12,16,20,24,32,40,48 weeks postoperatively ]
    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.
  • Characteristics and location of chronic postoperative pain [ Time Frame: 4,8,12,16,20,24,32,40,48 weeks postoperatively ]
    The common characteristics and location of CPP will also be summarized according to the patients' choice in survey.
  • Brief Pain Index [ Time Frame: 4,8,12,16,20,24,32,40,48 weeks postoperatively ]
    Brief Pain Index will be used to assess the impact of chronic postoperative pain on daily life.
Same as current
Not Provided
Not Provided
 
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
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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
48 Weeks
Not Provided
Probability Sample
Patients receiving surgery under general anesthesia during 2018 in Peking Union Medical College Hospital and other medical centers participating in this study
Chronic Postoperative Pain
Not Provided
Patients receiving surgery
No intervention will be administered. Patients included will be asked to return a questionnaire regarding chronic postoperative pain via app.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
Same as current
December 31, 2019
December 31, 2019   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact: Yuguang Huang, MD. 86-10-69152066 garypumch@163.com
Not Provided
 
 
NCT03363672
PUMCH-CPP
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: IPD will be shared via a database.
Time Frame: IPD will become available from 2018-1-1 to 2019-12-31.
Access Criteria: All the IPD will be included in a public database shared by all the medical centers participating in this study.
Huang YuGuang, Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Study Chair: Yuguang Huang, MD. Peking Union Medical College Hospital
Peking Union Medical College Hospital
November 2017