Genetic Variants and Postoperative Pain

NCT03489499 | Recruiting DMC

• 1 other identifier: 041/09c Schmerz
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.

Conditions

Analgesia; Surgical Procedure, Operative; Postoperative Pain

Keywords

postoperative pain; analgesics; patient reported outcome; pain related impairment; genetic association study

Outcome Measures

Primary Outcomes (1)

• Pain related impairment after surgery and its association to genetic and non-genetic variables

  Measured by the International Pain Outcomes Questionnaire, the Brief Pain Inventory (BPI): Numeric rating scale for pain intensities, affective and physical interference; Composite score = pain interference total scores (PITS scale 0-10) resulting in no interference (PITS=0), mild interference (PITS \>0 and \<2), moderate interference (PITS 2-5) and severe interference (PITS \>5)

  day of surgery up to 1 year after surgery

Secondary Outcomes (3)

• Association of genetic and non-genetic variables with analgesic consumption

  day of surgery up to one year after surgery

• Association of genetic and non-genetic variables with pain related outcome of patients 1 year after surgery

  Up to one year after surgery

• Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain

  up to one year after surgery

Study Arms (1)

All patients

Patients undergoing elective surgery with anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective surgery

You may qualify if:

• years and older
• Written informed consent
• Elective surgery
• Patients' ability to understand the purpose of the study

You may not qualify if:

• No informed consent
• Cognitive impairment

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (plasma and cells) or mucosal swab

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ulrike Stamer, Prof. MD

  Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern

  STUDY CHAIR

• Ulrike M Stamer, MD

  Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrike M Stamer, Prof. MD

CONTACT

0041-316329995; ulrike.stamer@dbmr.unibe.ch

Frank Stüber, Prof. MD

CONTACT

0041-316322483; frank.stueber@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 5, 2018
• Study Start: January 2, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CH (1)