Pain Predict Genetics

NCT ID: NCT02383342

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-12

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Acute Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Han G Brunner, Prof. PhD.

Role: STUDY_DIRECTOR

Radboud University Medical Center

Barbara Franke, Prof. PhD.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Gert Jan Scheffer, Prof. PhD.

Role: STUDY_CHAIR

Radboud University Medical Center

Rianne van Boekel, PhD.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Kris Vissers, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboudumc

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Rianne van Boekel, PhD.

Role: CONTACT

Kris Vissers, PhD

Role: CONTACT

Facility Contacts

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Rianne van Boekel, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36446453 (View on PubMed)

Other Identifiers

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NL26908.091.12

Identifier Type: -

Identifier Source: org_study_id

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