Postoperative PainNCT03489499
Genetic Variants and Postoperative Pain
An observational study of Postoperative Pain and Analgesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Analgesia, Surgical Procedure, Operative
- How many people
- 5,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2011to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients scheduled for elective surgery
Who may be able to join
- 18 years and older
- Written informed consent
- Elective surgery
- Patients' ability to understand the purpose of the study
Who cannot join
- No informed consent
- Cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Bern, 3010
Ulrike Stamer, Professor MD, 041-316329995, ulrike.stamer@dbmr.unibe.ch
Lan Zhang, PhD, 0041-316328872, lan.zhang@unibe.ch
About this study
Prospective observational study to analyse patients' pain related outcome after surgery and ist association to genetic variants and non-genetic variables.
Read the 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.
- Conditions
- Postoperative Pain, Analgesia, Surgical Procedure, Operative
- Keywords
- postoperative pain, analgesics, patient reported outcome, pain related impairment, genetic association study
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients undergoing elective surgery with anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day of surgery up to 1 year after surgery
Secondary outcomes (3)
Association of genetic and non-genetic variables with analgesic consumption
analgesic consumption
Measured: 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)
Measured: 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)
Measured: up to one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start2 Jan 2011
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrike Stamer, Prof. MD, Study chair, Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of BernUlrike M Stamer, MD, Principal investigator, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489499
- Sponsor's protocol ID
- 041/09c Schmerz
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants and Postoperative Pain
- ClinicalTrials.gov ID
- NCT03489499
- Acronym / sponsor ID
- 041/09c Schmerz
- Conditions
- Postoperative Pain, Analgesia, Surgical Procedure, Operative
- Keywords
- postoperative pain, analgesics, patient reported outcome, pain related impairment, genetic association study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 2 Jan 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –Patients undergoing elective surgery with anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective surgery
Key inclusion criteria (4 listed)
- 18 years and older
- Written informed consent
- Elective surgery
- Patients' ability to understand the purpose of the study
Key exclusion criteria (2 listed)
- No informed consent
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain related impairment after surgery and its association to genetic and non-genetic variables
Time frame: 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)
3 secondary outcomes
Association of genetic and non-genetic variables with analgesic consumption
Time frame: 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
Time frame: Up to one year after surgery
Association of genetic and non-genetic variables with chronic neuropathic postsurgical pain
Time frame: up to one year after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulrike Stamer, Prof. MD study chair
Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern
Ulrike M Stamer, MD principal investigator
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Analgesia, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrike M Stamer, Prof. MD (0041-316329995, ulrike.stamer@dbmr.unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain related impairment after surgery and its association to genetic and non-genetic variables (time frame: day of surgery up to 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.