ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence, Impact and Predictors of Chronic Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease
Chronic Postoperative Pain

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 48 Weeks
Official Title: Evaluation of the Prevalence and Impact of Chronic Postoperative Pain and Risk Factor Analysis: a Multi-center Prospective Cohort Study
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort
Patients receiving surgery
No intervention will be administered. Patients included will be asked to return a questionnaire regarding chronic postoperative pain via app.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients receiving surgery under general anesthesia during 2018 in Peking Union Medical College Hospital and other medical centers participating in this study
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363672


Contacts
Contact: Yuguang Huang, MD. 86-10-69152066 garypumch@163.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Yuguang Huang, MD. Peking Union Medical College Hospital

Responsible Party: Huang YuGuang, Chairman of anesthesisology department, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03363672     History of Changes
Other Study ID Numbers: PUMCH-CPP
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Huang YuGuang, Peking Union Medical College Hospital:
Chronic Postoperative Pain
Daily Life
Risk Factor

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms