Genetic Variants and Postoperative Pain

Recruiting

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

• Registration Number: NCT03489499
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain related impairment after surgery and its association to genetic and non-genetic variables	day of surgery up to 1 year after surgery	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)

Secondary Outcome Measures

Name	Time	Method
Association of genetic and non-genetic variables with analgesic consumption	day of surgery up to one year after surgery	analgesic consumption
Association of genetic and non-genetic variables with pain related outcome of patients 1 year after surgery	Up to one 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)
Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain	up to one year after surgery	Measured by a neuropathic pain questionnaire (number of neuropathic symptoms; at least three neuropathic symptoms are categorized as positive)

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern; 🇨🇭 Bern, Switzerland