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Comparison between intraoperative administered wound catheter for continuous local anaesthetic infusion versus oral pain therapy for the treatment of acute and chronic pain after neck dissection because of head and neck cancer - a prospective observational study.

Comparison between intraoperative administered wound catheter for continuous local anaesthetic infusion versus oral pain therapy for the treatment of acute and chronic pain after neck dissection because of head and neck cancer - a prospective observational study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009378
Enrollment
60
Registered
2015-11-19
Start date
2015-12-01
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

C32

Interventions

Group 1: Oral pain medication consisting of a non-opioid (for example metamizole) and if required an opioid (tilidine or oxycodone). Group 2: Intraoperative application of a wound catheter. It will be

Sponsors

Schmerzzentrum der Klinik für Anästhesiologie und Operative Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactJohannes Löser

Schmerzzentrum, Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln

johannes.loeser@uk-koeln.de0221-47884800

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026