Genetic Variants and Postoperative Pain

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03489499

Enrollment

5000

Registered

2018-04-05

Start date

2011-01-02

Completion date

2027-04-30

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Postoperative Pain, Surgical Procedure, Operative

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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)

Countries

Switzerland

Contacts

Primary ContactUlrike M Stamer, Prof. MD

ulrike.stamer@dbmr.unibe.ch0041-316329995

Backup ContactFrank Stüber, Prof. MD

frank.stueber@insel.ch0041-316322483

Outcome results