Chronic Post Operative PainNCT05816174
Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents
An observational study of Chronic Post Operative Pain, run by Helen Koechlin at 3 sites in Switzerland.
Trial summary
Chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. After major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Chronic Post Operative Pain
- How many people
- 281 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 1 Nov 2023to Jan 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 8 to 18 years
- All sexes
- Child, Adult
Study population: Participants between the ages of 8 and 18 years who have a planned orthopedic surgery in one of the participating hospitals will be approached. Participating hospitals are large Swiss university children's hospital.
Who may be able to join
- Children and adolescents aged between 8 and 18 years
- Planned orthopedic surgery requiring in-patient care in one of the participating children's hospitals
- Able to read and understand German
Who cannot join
- Serious comorbid health condition (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication)
- Prior major orthopedic surgery (e.g., prior spine surgery)
- Parent/caregiver and child not able to read and understand German
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jana Hochreuter, MSc contact
Switzerland3 sites, 3 recruiting
- Recruiting
University Children's Hospital Basel
Basel
Carol-Claudius Hasler, Prof, carolclaudius.hasler@ukbb.ch
- Recruiting
University Children's Hospital Zurich
Zurich, 8032
Helen Koechlin, PhD, helen.koechlin@kispi.uzh.ch
Jana Hochreuter, MSc., jana.hochreuter@kispi.uzh.ch
- Recruiting
University Hospital Balgrist
Zurich
Thomas Dreher, Prof, thomas.dreher@kispi.uzh.ch
About this study
Official title: Child and Parent Emotion-related Risk and Resilience Factors Associated With the Transition From Acute to Chronic Pain After Surgery: A Prospective Longitudinal Study
Chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. After major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. Emotion-related factors such as the variability of emotions, how emotions are regulated, and how well someone is able to differentiate between different emotions have in part been studied in other types of chronic pain. To date, no study examined emotion-related factors in the development and maintenance of chronic postsurgical pain. This observational study includes five assessment time points, one before and four after major surgery, with the goal to identify emotion-related factors that increase or decrease the risk for the development of chronic postsurgical pain.
- Conditions
- Chronic Post Operative Pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postsurgical pain
Chronic postsurgical pain as defined by the International Association for the Study of Pain, i.e.: greater than minimal pain (pain intensity ≥ 3) on more than 50% of a 7 days period, and impairment in health-related quality of life (score of < 74.9 on the Pediatric Quality of Life Inventory, PedsQL). This results in a binary outcome: chronic postsurgical pain yes vs no.
Measured: 3 months
Pain trajectories
Description of pain trajectories over time, i.e., from baseline through FU3 (at 12 months after surgery). We will estimating group-based trajectory models using participants' Numeric Rating Scale (NRS) values of pain intensity at each time point. Higher ratings on the numeric rating scale indicate more pain.
Measured: 12 months
Emotion-related trajectories
Description of emotion-related trajectories over time, i.e., from baseline through Follow-up 3 (at 12 months after surgery). We will estimating group-based trajectory models using participants' Visual Analogue Scale (VAS) values of emotional state to calculate emotion differentiation, emotion variability, and emotion regulation at each time point and describe changes over time. Higher values for emotional variability indicate broader range of emotional fluctuations around an individual's mean. Emotion differentiation will be calculated by means of intraclass correlations, with high consistency across predefined episodes indicate poorer differentiation.
Measured: 12 months
Secondary outcomes (1)
Physical activity
Number of steps taken by patients per day, as measured by an ambulatory, non-invasive activity-monitoring device worn around the wrist. Higher number of steps taken suggests more physical activity.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Nov 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Post Operative 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
- 281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helen Koechlin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Helen Koechlin, University Children's Hospital, Zurich
- Investigators
- Helen Koechlin, PhD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816174
- Sponsor's protocol ID
- LORRIS
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hochreuter J, Dreher T, Hasler CC, Canonica S, Locher C, Held U, Rabbitts J, Koechlin H. Longitudinal Resilience and Risk Factors in Pediatric Postoperative Pain (LORRIS): Protocol for a Prospective Longitudinal Swiss University Children's Hospitals-Based Study. BMJ Open. 2024 Mar 28;14(3):e080174. doi: 10.1136/bmjopen-2023-080174.
PubMed 38548365
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child and Parent Emotion-related Risk and Resilience Factors Associated With the Transition From Acute to Chronic Pain After Surgery: A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT05816174
- Acronym / sponsor ID
- LORRIS
- Conditions
- Chronic Post Operative Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- Helen KoechlinUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 Apr 2023 (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.
Chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. After major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. Emotion-related factors such as the variability of emotions, how emotions are regulated, and how well someone is able to differentiate between different emotions have in part been studied in other types of chronic pain. To date, no study examined emotion-related factors in the development and maintenance of chronic postsurgical pain. This observational study includes five assessment time points, one before and four after major surgery, with the goal to identify emotion-related factors that increase or decrease the risk for the development of chronic postsurgical pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Participants between the ages of 8 and 18 years who have a planned orthopedic surgery in one of the participating hospitals will be approached. Participating hospitals are large Swiss university children's hospital.
Key inclusion criteria (3 listed)
- Children and adolescents aged between 8 and 18 years
- Planned orthopedic surgery requiring in-patient care in one of the participating children's hospitals
- Able to read and understand German
Key exclusion criteria (3 listed)
- Serious comorbid health condition (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication)
- Prior major orthopedic surgery (e.g., prior spine surgery)
- Parent/caregiver and child not able to read and understand German
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
Chronic postsurgical pain
Time frame: 3 months
Chronic postsurgical pain as defined by the International Association for the Study of Pain, i.e.: greater than minimal pain (pain intensity ≥ 3) on more than 50% of a 7 days period, and impairment in health-related quality of life (score of < 74.9 on the Pediatric Quality of Life Inventory, PedsQL). This results in a binary outcome: chronic postsurgical pain yes vs no.
Pain trajectories
Time frame: 12 months
Description of pain trajectories over time, i.e., from baseline through FU3 (at 12 months after surgery). We will estimating group-based trajectory models using participants' Numeric Rating Scale (NRS) values of pain intensity at each time point. Higher ratings on the numeric rating scale indicate more pain.
Emotion-related trajectories
Time frame: 12 months
Description of emotion-related trajectories over time, i.e., from baseline through Follow-up 3 (at 12 months after surgery). We will estimating group-based trajectory models using participants' Visual Analogue Scale (VAS) values of emotional state to calculate emotion differentiation, emotion variability, and emotion regulation at each time point and describe changes over time. Higher values for emotional variability indicate broader range of emotional fluctuations around an individual's mean. Emotion differentiation will be calculated by means of intraclass correlations, with high consistency across predefined episodes indicate poorer differentiation.
1 secondary outcome
Physical activity
Time frame: 3 months
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 29 Apr 2026.
- Background: PubMed 38548365Hochreuter J, Dreher T, Hasler CC, Canonica S, Locher C, Held U, Rabbitts J, Koechlin H. Longitudinal Resilience and Risk Factors in Pediatric Postoperative Pain (LORRIS): Protocol for a Prospective Longitudinal Swiss University Children's Hospitals-Based Study. BMJ Open. 2024 Mar 28;14(3):e080174. doi: 10.1136/bmjopen-2023-080174.
- Individual participant dataSharing planned: Undecided
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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.
Jana Hochreuter, MSc contact
Helen Koechlin, PhD principal investigator
University Children's Hospital, Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Post Operative Pain, run by Helen Koechlin at 3 sites 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 3 inclusion and 3 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Helen Koechlin, PhD (4144 266 83 36, helen.koechlin@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postsurgical pain (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05816174, which also lists 1 linked publication.
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 29 Apr 2026.