PPG: Pain Predict Genetics

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02383342
Collaborator
(none)
10,000
1
141.6
70.6

Study Details

Study Description

Brief Summary

Pain is the most frequent cause of suffering and disability in society. Despite considerable involvement of genetic factors in pain sensation and sensitivity, the individual genes involved remain largely unidentified.

In this project the investigators will follow patients undergoing elective major surgery for the development of acute and chronic pain. The investigators will search for clinical as well as genetic factors that can predict the development of pain. These can serve as biomarkers to predict acute and chronic pain development and progression in individual patients and help early individual treatment adaptation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pain is the most frequent cause of suffering and disability in society. Chronic pain seriously impairs quality of life of millions of people worldwide. 10-50% of surgical patients report chronic pain after surgery; up to 10% report severe pain. Thus, chronic pain is a significant medical and financial burden to society.

    Despite considerable involvement of genetic factors in pain sensation and sensitivity, individual genes involved remain largely unidentified. Knowledge of genetic factors, their phenotypic expression in pain processing, and their link to neuronal correlates can improve understanding of pain aetiology and processes involved in pain perception and chronification. Also, they can serve as biomarkers to predict chronic pain development and progression in patients and help early individual treatment adaptation.

    In this study the investigators will establish a prospective database and biobank of patients undergoing elective major surgery. Using data from the database and biobank, the investigators will identify genetic factors contributing to development of acute and chronic pain after surgery.

    Over a period of 10 years the investigators will prospectively include up to 10,000 patients visiting the hospital for elective major surgery. Data defining participants demographics, medical history and questionnaire data will be collected and stored in dedicated databases. Additional details (surgery and perioperative management, pain processing phenotypes and surgical and pain outcomes) will be stored.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Development of Postoperative Pain; Clinical and Genetic Factors
    Actual Study Start Date :
    May 12, 2015
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Genetic risk factors for the development of acute pain using a visual analogue scale. [7 days]

      All patients will be followed for 1 year after elective surgery, during this period the investigators will collect acute pain measures using a visual analogue scale (ranging from 0 (no pain) -10 (pain)) before the operation and 1, 2, 3 and 7 days after the operation.

    2. Genetic risk factors for the development of chronic pain (defined as pain (yes or no) for more than 3 months in one specific body area). [6 months]

      All patients will be followed for 1 year after elective surgery, during this period the investigators will collect chronic pain measures using a questionnaire before the operation and 1 week, 3 months and 6 months. Chronic pain is defined as pain at a specific body side (yes/no) for more than 3 months.

    Secondary Outcome Measures

    1. If the pain influences daily functioning will be assesed with the pain disability index. [6 months]

      The pain disability index will be used to assess whether the observed acute or chronic pain influences daily life. The pain disability index will be collected before the operation and at week 1, 3 months and 6 months.

    2. Is fear before an operation related to the development of acute and chronic pain after the operation. [once pre-operatively]

      The Amsterdam Preoperative Fear and Information Scale (APAIS)(Moerman et al. Anesth Analg. 1996 Mar;82(3):445-51) will be used to assess whether the observed acute or chronic pain can be linked to fear before an operation. The measure will be collected before the operation. The scores on the anxiety scale of the APAIS range from 4 (not anxious) to 20 (highly anxious). And the scores on the information scale of the APAIS range from 2 (no need for information) to 10 (high need for information).

    3. Is the Pain Catastrophizing Scale related to the development of acute and chronic pain after the operation. [once pre-operatively]

      The Pain Catastrophizing Scale (Sullivan et al. Psychol Assess 1995;7:524-32) will be used to assess whether the observed acute or chronic pain are association with the Pain Catastrophizing Scale. The Pain Catastrophizing Scale contains 13 items (all items are rated on a 5 point scale). The measure will be collected before the operation.

    4. Is Pain Sensitivity related to the development of acute and chronic pain after the operation. [once pre-operatively]

      The Pain Sensitivity Questionnaire (PSQ; Ruscheweyh et al.Pain. 2009 Nov;146(1-2):65-74) will be used to assess whether the observed acute or chronic pain are association with a higher pain sensitivity. This questionnaire consists of 17 questions, each describing a daily life situation on a numeric rating scale ranging from 0 (not painful at all) to 10 (worst pain imaginable). The pain sensitivity questionnaire will be collected before the operation.

    5. Is the size of the incision made during the operation associated with pain development. [6 months]

      The incision size will be measured and reported by the patients to investigate whether this is linked to the development of acute or chronic pain

    6. Is days in hospital after the operation associated with pain development. [6 months]

      Number of days in the hospital will be recorded to investigate whether this is linked to the development of acute or chronic pain.

    7. Is medication use after the operation assocaited with pain development. [6 months]

      Type of (pain)medication and duration of medication use will be recorded by questionnaires and electronic health records. The investigators will analyse if medication type or duration of medication use is associated with pain development.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Patients:
    • Ages 18 - 80 years, consenting, planned surgery, able to understand and answer questionnaires.
    Exclusion Criteria:
    • Non-consent, inability to give consent, unplanned and emergency surgery.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Netherlands 6500HB

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Study Director: Han G Brunner, Prof. PhD., Radboud University Medical Center
    • Principal Investigator: Barbara Franke, Prof. PhD., Radboud University Medical Center
    • Principal Investigator: Marieke JH Coenen, PhD., Radboud University Medical Center
    • Study Chair: Gert Jan Scheffer, Prof. PhD., Radboud University Medical Center
    • Principal Investigator: Rianne van Boekel, PhD., Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02383342
    Other Study ID Numbers:
    • NL26908.091.12
    First Posted:
    Mar 9, 2015
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Radboud University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2022