Genetic Variants and Postoperative Pain

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Analgesia; Surgical Procedure, Operative

Detailed Description

Background

Severe acute pain as well as long-lasting pain after surgery and pain-related interference of daily activities are frequent. Some risk factors for severe pain after surgery in adults have been described, e.g. younger age and pre-existing chronic pain. The question arises whether a specific genetic background is related to an unfavorable pain outcome.

Objective

The aim of this study is to investigate clinical and genetic variables and their possible association to severe acute postoperative pain, higher analgesic consumption and the development of chronic postsurgical pain.

Methods

Prospective observational study investigating clinical, patient related, surgery related and anesthesia related variables as well as genetic variants and their possible association to patients' pain related outcome after surgery.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Ulrike M Stamer, Prof. MD; Phone Number: 0041-316329995; Email: ulrike.stamer@dbmr.unibe.ch
• Study Contact Backup: Name: Frank Stüber, Prof. MD; Phone Number: 0041-316322483; Email: frank.stueber@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
    • Principal Investigator: Ulrike M Stamer, MD
    • Contact: Ulrike Stamer, Professor MD; Phone Number: 041-316329995; Email: ulrike.stamer@dbmr.unibe.ch
    • Contact: Lan Zhang, PhD; Phone Number: 0041-316328872; Email: lan.zhang@unibe.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective surgery

Description

Inclusion Criteria:

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

Exclusion Criteria

• No informed consent
• Cognitive impairment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All patients; Patients undergoing elective surgery with anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of genetic and non-genetic variables with analgesic consumption	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	Measured by the Brief Pain Inventory (BPI) as pain interference total score 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). Change of pain related impairment over time (before surgery, 2 days after surgery, 6 and 12 months after surgery)	Up to one year after surgery
Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain	Measured by a neuropathic pain questionnaire (number of neuropathic symptoms; at least three neuropathic symptoms are categorized as positive)	up to one year after surgery

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Ulrike M Stamer, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern; Study Chair: Ulrike Stamer, Prof. MD, Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: analgesics; postoperative pain; patient reported outcome; genetic association study; pain related impairment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia
• Other Study ID Numbers: 041/09c Schmerz