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Chronic PainPPGNCT02383342

Pain Predict Genetics

An observational study of Chronic Pain and Acute Pain, run by Radboud University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Pain, Acute Pain
How many people
10,000 participants
Where
1 siteNetherlands
Study dates
12 May 2015to Mar 2029
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients undergoing elective major surgery at Radboud university medical center (Nijmegen, The Netherlands) Patients will be recruited prospectively and consecutively via the anaesthetic preoperative outpatients' clinic.

Who may be able to join

  • Patients:
  • Ages 18 - 80 years, consenting, planned surgery, able to understand and answer questionnaires.

Who cannot join

  • Non-consent, inability to give consent, unplanned and emergency surgery.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen, 6500HB

Other trials in Netherlands

About this study

Official title: Development of Postoperative Pain; Clinical and Genetic Factors

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.

Read the 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.

Keywords
Clinical predictors, Genetic Factors
Medical subject headings
Chronic Pain, Acute Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 7 days

  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).

    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.

    Measured: 6 months

Secondary outcomes (7)

  1. If the pain influences daily functioning will be assesed with the pain disability index.

    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.

    Measured: 6 months

  2. Is fear before an operation related to the development of acute and chronic pain after the operation.

    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).

    Measured: once pre-operatively

  3. Is the Pain Catastrophizing Scale related to the development of acute and chronic pain after the operation.

    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.

    Measured: once pre-operatively

  4. Is Pain Sensitivity related to the development of acute and chronic pain after the operation.

    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.

    Measured: once pre-operatively

  5. Is the size of the incision made during the operation associated with pain development.

    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

    Measured: 6 months

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

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

    Measured: 6 months

  7. Is medication use after the operation assocaited with pain development.

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2015 (estimated)
  2. Study start12 May 2015
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02383342
Sponsor's protocol ID
NL26908.091.12
Acronym
PPG
Status last verified
Aug 2026
First submitted
28 Jan 2015
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Li S, van Boekel RLM, van den Heuvel SAS, Coenen MJH, Vissers KCP. Pain predict genetics: protocol for a prospective observational study of clinical and genetic factors to predict the development of postoperative pain. BMJ Open. 2022 Nov 29;12(11):e066134. doi: 10.1136/bmjopen-2022-066134.

    PubMed 36446453

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Acute Pain, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Genetic risk factors for the development of acute pain using a visual analogue scale. (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02383342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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