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Effect of establishing a standardized, individually adapted pain therapy to reduce acute postoperative pain in ophthalmic surgery - a prospective observational study

Effect of establishing a standardized, individually adapted pain therapy to reduce acute postoperative pain in ophthalmic surgery - a prospective observational study - “Cologne STandardized Ophthalmic pain thErapY – Prospective observAtIoNal trial (STOP-EYE-PAIN-Trial)”

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00030059
Enrollment
350
Registered
2022-08-23
Start date
2022-09-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H57.1

Interventions

Group 1: In the planned clinical observational study, male and female patients undergoing enucleation, orbitotomy, corneal transplantation or other eye surgery will be examined. Patients will receive
0=no pain
10=maximal pain) preoperatively and on all postoperative inpatient days. Quality of life is measured on postoperative day 3 using SF36 questionnaire (Short Form 36, psychometric questionnaire, see App

Sponsors

Universitätsklinikum KölnKlinik für Anästhesiologie und Operative Intensivemdizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing orbitotomy, enucleation of the eye, corneal transplantation or other eye surgery Minimum age 18 years Present, signed informed consent form Patient consent after detailed information about the study ASA classification I-III 50 - 120 kg body weight

Exclusion criteria

Exclusion criteria: Intolerance to ibuprofen, metamizole, tilidine, tramadol, oxycodone, or morphine Patients under 18 years of age Patients who have not signed a consent form Patients who could not be adequately informed due to language and comprehension problems. Patients who were not cleared for surgery after the premedication visit due to their pre-existing conditions released for surgery

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this observational study is pain severity reported on all postoperative days and at discharge.

Secondary

MeasureTime frame
Secondary endpoints are quality of life, (additional) analgesic consumption, adverse events, mortality, morbidity, and perioperative complications, e.g., wound healing disorders.

Countries

Germany

Contacts

Public ContactNicolas Leister

Universitätsklinikum KölnKlinik für Anästhesiologie und Operative Intenisvmedizin

nicolas.leister@uk-koeln.de0049-(0)-221/478-82058

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026