Pain Predict Genetics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Pain, Acute Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of Postoperative Pain; Clinical and Genetic Factors
Overview
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
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.
Primary outcome measures
- Genetic risk factors for the development of acute pain using a visual analogue scale. [Time frame: 7 days]
- 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). [Time frame: 6 months]
Secondary outcome measures (7)
- If the pain influences daily functioning will be assesed with the pain disability index. [Time frame: 6 months]
- Is fear before an operation related to the development of acute and chronic pain after the operation. [Time frame: once pre-operatively]
- Is the Pain Catastrophizing Scale related to the development of acute and chronic pain after the operation. [Time frame: once pre-operatively]
- Is Pain Sensitivity related to the development of acute and chronic pain after the operation. [Time frame: once pre-operatively]
- Is the size of the incision made during the operation associated with pain development. [Time frame: 6 months]
- Is days in hospital after the operation associated with pain development. [Time frame: 6 months]
- Is medication use after the operation assocaited with pain development. [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Netherlands · 1 center
- Radboudumc — Nijmegen
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. PMID 36446453
Identifiers
NCT: NCT02383342 · NL26908.091.12