NCT02383342

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2015Mar 2029

First Submitted

Initial submission to the registry

January 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2015

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

11.8 years

First QC Date

January 28, 2015

Last Update Submit

August 8, 2025

Conditions

Chronic PainAcute Pain

Keywords

Clinical predictorsGenetic Factors

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    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.

    6 months

Secondary Outcomes (7)

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

    6 months

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

    once pre-operatively

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

    once pre-operatively

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

    once pre-operatively

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

    6 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, 6500HB, Netherlands

RECRUITING

Related Publications (1)

  • 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: 36446453DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood for DNA

MeSH Terms

Conditions

Chronic PainAcute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Han G Brunner, Prof. PhD.

    Radboud University Medical Center

    STUDY DIRECTOR

  • Barbara Franke, Prof. PhD.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Gert Jan Scheffer, Prof. PhD.

    Radboud University Medical Center

    STUDY CHAIR

  • Rianne van Boekel, PhD.

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Kris Vissers, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rianne van Boekel, PhD.

CONTACT

rianne.vanboekel@radboudumc.nl

Kris Vissers, PhD

CONTACT

kris.vissers@radboudumc.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

March 9, 2015

Study Start

May 12, 2015

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

NL(1)