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| Name | Class |
|---|---|
| Grünenthal GmbH | INDUSTRY |
| University Hospital Muenster | OTHER |
| Hospital Ambroise Paré Paris | OTHER |
| Novartis Pharmaceuticals |
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PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.
In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee arthroplasty | Patients undergoing total knee arthroplasty |
| |
| Sternotomy | Patients undergoing sternotomy |
| |
| Breast | Patients undergoing breast surgery |
| |
| Endometriosis | Patients undergoing endometriosis-related surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospective data collection | Other | No intervention. It's a prospective data collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| WP 2 - Acute pain: Sensitivity to change | For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1. | 2019 - 2022 |
| WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP) | For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire. | 2019 - 2022 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective physical activity and sleep, measured with Actigraph devices | Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO "physical function" on day 7; | 01/2020 to 12/2021 |
| Association between other POD7 PROMs and activity/sleep |
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Inclusion Criteria:
Exclusion Criteria:
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For the groups 'Breast' and 'Endometriosis', only female patients can be included.
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Patients undergoing one of the following types of surgery: TKA, breast, sternotomy and endometriosis related surgery. Only female patients will be included in the Breast Surgery and Endometriosis group. For the other surgeries, there will not be a special preference in the distribution by sex or age for the recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Winfried Meissner, Prof. | Jena University Hospital | Study Chair |
| Hiltrud Liedgens, Dr. | Grünenthal GmbH | Study Chair |
| Esther Pogatzki-Zahn, Prof. | University Hospital Münster | Principal Investigator |
| Dominique Fletcher, Prof. | Hospital Ambroise Paré Paris | Principal Investigator |
| Shaloo Pandhi | Novartis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jena University Hospital | Jena | Thuringia | 07747 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41690858 | Derived | Roper L, Belton J, Weinmann C, Fletcher D, Lavand'homme P, Kalso E, Meissner W, Rosenberger DC, Segelcke D, Vollert J, Pogatzki-Zahn EM. Associations of baseline characteristics, patient-reported outcomes, and satisfaction with pain therapy with the patient's global impression of change: a prospective cohort study. Br J Anaesth. 2026 Apr;136(4):1341-1348. doi: 10.1016/j.bja.2026.01.010. Epub 2026 Feb 13. | |
| 41065659 |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| INDUSTRY |
| Hôpital Raymond Poincaré | OTHER |
| University of Helsinki | OTHER |
| University Hospital St Luc, Brussels | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| University Hospital, Geneva | OTHER |
| Orthopedic Center Santy, Lyon, France | UNKNOWN |
| University of Naples | OTHER |
| Hospital Clínico Universitario de Valladolid | OTHER |
| Cancer Center Porto, Portugal | UNKNOWN |
| Orthopedic Institute Banjika, Belgrade, Serbia | UNKNOWN |
| Cardiovascular Center Dedinje, Belgrade, Serbia | UNKNOWN |
| University of Homburg | OTHER |
| Barts & The London NHS Trust | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital Dresden | OTHER |
| University Hospital Bergmannsheil Bochum | OTHER |
| Infirmerie Protestante de Lyon | OTHER |
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Association between other POD7 PROMs and activity/sleep |
| 01/2020 to 12/2021 |
| Association between peri-operative processes and activity/sleep | Association between peri-operative processes and activity/sleep | 01/2020 to 12/2021 |
| Is decreased activity a predictor for chronic postsurgical pain? | Is decreased activity a predictor for chronic postsurgical pain on POM6? | 01/2020 to 12/2021 |
| Do activity trajectories since surgery parallel trajectories of other outcomes? | Do activity trajectories since surgery parallel trajectories of other outcomes? | 01/2020 to 12/2021 |
| Correlation of activity difference between POD5-7 and preop with POD7 oucomes | Correlation of activity difference between POD5-7 and preop with POD7 oucomes | 01/2020 to 12/2021 |
| Association between ambient light intensity and outcomes on POD7 | Association between ambient light intensity and outcomes on POD7 | 01/2020 to 12/2021 |
| Derived |
| Vollert J, Egert VM, Segelcke D, Fletcher D, Kalso E, Kemp H, Lavand'homme P, Komann M, Weinmann C, Meissner W, Pogatzki-Zahn EM. Minimal Clinically Important Changes of Patient-reported Outcome Measures for Acute Postsurgical Pain. Anesthesiology. 2026 Jan 1;144(1):143-153. doi: 10.1097/ALN.0000000000005792. Epub 2025 Oct 9. |
| 38414426 | Derived | Martinez V, Lehman T, Lavand'homme P, Harkouk H, Kalso E, Pogatzki-Zahn EM, Komann M, Meissner W, Weinmann C, Fletcher D. Chronic postsurgical pain: A European survey. Eur J Anaesthesiol. 2024 May 1;41(5):351-362. doi: 10.1097/EJA.0000000000001974. Epub 2024 Feb 27. |
| 38016907 | Derived | Vollert J, Segelcke D, Weinmann C, Schnabel K, Fuchtmann F, Rosenberger DC, Komann M, Maessen T, Sauer L, Kalso E, Fletcher D, Lavand'homme P, Kaiser U, Liedgens H, Meissner W, Pogatzki-Zahn EM. Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study. Br J Anaesth. 2024 Jan;132(1):96-106. doi: 10.1016/j.bja.2023.10.020. Epub 2023 Nov 28. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |