Clinical trial NCT02383342: Pain Predict Genetics
Official title: Development of Postoperative Pain; Clinical and Genetic Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Acute Pain
Keywords: Clinical predictors
Genetic Factors
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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.

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.

Primary outcomes:
measure: Genetic risk factors for the development of acute pain using a visual analogue scale.
timeFrame: 7 days
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: If the pain influences daily functioning will be assesed with the pain disability index.
timeFrame: 6 months
measure: Is fear before an operation related to the development of acute and chronic pain after the operation.
timeFrame: once pre-operatively
measure: Is the Pain Catastrophizing Scale related to the development of acute and chronic pain after the operation.
timeFrame: once pre-operatively
measure: Is Pain Sensitivity related to the development of acute and chronic pain after the operation.
timeFrame: once pre-operatively
measure: Is the size of the incision made during the operation associated with pain development.
timeFrame: 6 months
measure: Is days in hospital after the operation associated with pain development.
timeFrame: 6 months
measure: Is medication use after the operation assocaited with pain development.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Han G Brunner, Prof. PhD.
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Barbara Franke, Prof. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Gert Jan Scheffer, Prof. PhD.
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: Rianne van Boekel, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Kris Vissers, PhD
role: PRINCIPAL_INVESTIGATOR
References: