C32
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients who are planned for an unilateral or a bilateral neck dissection and who are released for the operation after completion of all preoperative examinations. - Minimum age of 18 years. - Present written consent after detailed information about the study. - ASA classification I-III - 50 – 120 kg body weight
Exclusion criteria
Exclusion criteria: - Intolerance against ropivacaine or other local anaesthetics of amide type. - Preexisting chronic pain. - Age under 18 years. - No presence of informed consent for the study. - No release for the operation after completion of all preoperative examinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pain with an intensity more than NRS 0 (Numeric rating scale, 0 = no pain; 10 = maximum pain) 3 months after operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Neuropathic pain component: measured with Pain Detect Questionnaire at every postoperative day and 2, 4, 6 and 12 months postoperatively. - Pain intensity: measured with Numeric Rating Scale (0 - 10) at every postoperative day and 2, 4, 6 and 12 months postoperatively. - Quality of Life: measured with SF36 questionnaire at every postoperative day and 2, 4, 6 and 12 months postoperatively. - (Additional) use of pain medication: registration of the amount of administered Non-opioids and Opioids (morphine equivalence dose) at every postoperative day and 2, 4, 6 and 12 months postoperatively. - Mortality, measured during hospital stay. - Morbidity: measured during hospital stay. - Therapy caused adverse side effects: measured at every postoperative day and 2, 4, 6 and 12 months postoperatively. - perioperative complications, for example dysfunction in wound healing,measured during hospital stay. | — |
Countries
Germany
Contacts
Schmerzzentrum, Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln