Chronic Postsurgical Pain (CPSP), pain developing or increasing in intensity after a surgical procedure or a tissue injury (involving any trauma including burns) and persisting beyond the healing process, i.e. at least 3 months after surgery or tissue trauma
Conditions
Interventions
Group 1: Arm 1 (Group A): osteosynthesis after traumatic fracture (surgical)
Arm 2 (Group B): conservative fracture management
Arm 3 (Group C, controlgroup): surgery without prior fracture (e.g., joint replacement)
Sponsors
Klinik für Anästhesiologie, Intensiv- und Schmerztherapie, Klinikdirektor: Prof. Dr. Peter K. Zahn, BG Univeritätsklinikum Bergmannsheil Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sufficient German language skills; Group A: traumatic extremity/spine fracture requiring internal fixation; Group B: traumatic fracture treated conservatively; Group C: surgery without prior fracture
Exclusion criteria
Exclusion criteria: > 7 days between fracture and surgery; periprosthetic fracture or re-fracture; re-operation in fracture area (prior surgery or initial external fixation); inability to consent; involvement in study conduct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Differences in NRS at rest/movement on post operative day 1/3/5 as risk factor for CPS (NRS 0-10, assessment time points: D1, D3, D5); (2) CPS incidence at 3 months, pain intensity assessed by NRS (0–10); NRS = 3 at the surgical site; assessment time point: three Months (M3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analysis of differences in pain intensity (NRS) at rest and during movement in patients with chronic post-surgical pain (CPSP) three months after the fracture event (assessment time point: 3 months). 2. Evaluation of additional preoperative risk factors for the development of chronic pain, including neuropathic pain symptoms (DN4i), pain intensity at rest (NRS), and female sex. 3. Determination of cytokine profiles associated with the development of chronic pain in patients before and after fracture-related surgery, based on post-traumatic/preoperative cytokine levels measured on postoperative day 3 and at three months after the fracture event. 4. Identification of biomarkers for chronic pain development using chemokines and adipokines assessed post-traumatically/preoperatively, on postoperative day 3, and at three months following the fracture event. 5. Assessment of fracture-specific factors, including fracture type, treatment modality (operative vs. conservative management), time from fracture to hospital admission and/or surgery, fracture consolidation, and fracture progression. 6. Analysis of surgery-related factors, including surgical technique, duration of surgery, type of anesthesia, and secondary complications (e.g. surgical revision, bleeding complications, neurological complications such as nerve root involvement, implant loosening or failure, and postoperative intensive care treatment). 7. Assessment and analysis of pupillary dilation as a pupillometry parameter at the following time points: post-traumatic/preoperative, during treatment, postoperative day 3, and three months after the fracture event, to objectively quantify pain intensity over the course of treatment. 8. Analysis of sex-specific differences in pain intensity (NRS), incidence of chronic pain, risk factors, pupillary dilation, and biomarker profiles assessed post-traumatically/preoperatively, on postoperative days 1, 3, and 5, and at three months after the fracture event. 9. Com | — |
Countries
Germany
Contacts
Public ContactAdeline Wenzel
Klinik für Anästhesiologie, Intensiv- und Schmerztherapie, Klinikdirektor: Prof. Dr. Peter K. Zahn, BG Univeritätsklinikum Bergmannsheil Bochum
Outcome results
None listed