NCT05315596

Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery

Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Little is known about pain-related outcomes experienced by patients in the first few weeks after surgery, once they are discharged from hospital. This study aims to characterize pain, pain-related interference, and early neuropathic pain in the sub-acute phase after surgery.

Detailed description

A high proportion of patients experience moderate to severe pain after surgery. However, most of the knowledge about this comes from studies where patients are evaluated in the hours and up until the first postoperative day. Alternatively, patients are assessed several months (eg 3 or later) after surgery, to evaluate the development of chronic pain related to surgery (CPSP) and most patients do not develop CPSP. This study aims to learn how patients recover concerning pain and function once they return home after surgery. How long is it before they can resume their daily activities and to do so in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical incision or it is more widespread? There is little knowledge as to whether there are signs of nerve injury in the days close to surgery. This type of pain might lead to chronic pain in later stages. Patients will be assessed at three time points: the first day after surgery, the 7th day after surgery, and 1 month. The information we obtain will offer healthcare providers, from multiple hospitals, information about the care they provide to their patients for pain while patients are still in hospital and insights as to how the care might be improved, once they are discharged.

Conditions

• Pain, Postoperative
• Adult
• Pain Measurement
• Functional Status
• Pain Management
• Neuralgia
• Analgesia

Timeline

• Start date: 2022-02-01
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2022-04-07
• Last updated: 2022-04-07

Locations

16 sites across 2 countries: Germany, Mexico