Genetic Variants and Postoperative Pain

Postoperative Pain Clinical Trial

Official title:

Genetic Variants and Postoperative Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03489499
• Other study ID #: 041/09c Schmerz
• Status: Recruiting
• Start date: January 2011
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Ulrike M Stamer, Prof. MD
• Phone: 0041-316329995
• Email: ulrike.stamer[@]dbmr.unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: April 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain
• Surgical Procedure, Operative

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association of genetic and non-genetic variables with analgesic consumption	analgesic consumption	day of surgery up to one year after surgery
Secondary	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
Secondary	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