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.
- Conditions
- C32Malignant neoplasm of larynx
- Registration Number
- DRKS00009378
- Lead Sponsor
- Schmerzzentrum der Klinik für Anästhesiologie und Operative Intensivmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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
- 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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of pain with an intensity more than NRS 0 (Numeric rating scale, 0 = no pain; 10 = maximum pain) 3 months after operation.
- Secondary Outcome Measures
Name Time Method - Neuropathic pain component: measured with Pain Detect Questionnaire at every postoperative day and 2, 4, 6 and 12 months postoperatively.<br>- Pain intensity: measured with Numeric Rating Scale (0 - 10) at every postoperative day and 2, 4, 6 and 12 months postoperatively.<br>- Quality of Life: measured with SF36 questionnaire at every postoperative day and 2, 4, 6 and 12 months postoperatively.<br>- (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.<br>- Mortality, measured during hospital stay. <br>- Morbidity: measured during hospital stay. <br>- Therapy caused adverse side effects: measured at every postoperative day and 2, 4, 6 and 12 months postoperatively.<br>- perioperative complications, for example dysfunction in wound healing,measured during hospital stay.