J35.0 C14.0
Conditions
Interventions
Group 1: The control group is planned to exist of 50 patients (25 patients after tonsillectomy and 25 patients after tumour resection). Patients are going to receive analgesic treatment according to t
Sponsors
HNO-Klinik Universitätsklinikum Erlangen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria are as follows: patients undergoing bilateral total tonsillectomy or a pharyngeal tumour resection. In addition: - minimum age of 18 years. - sufficient cognitive and language skills in order to understand the content of the questionnaire. - informed written consent after detailed clarification about the study. - American Society of Anaesthesiologists (ASA) status I-III. - Body weight of 50-120 kg.
Exclusion criteria
Exclusion criteria: Single sided and partial tonsillectomy, tonsillectomy à chaud, tonsillectomy due to oncologic indication, medical history of pre-existing chronic pain, age of under 18 years, prevalence of significant central nervous system disease, obstructive sleep apnoea and/or refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is defined as the daily average and maximum pain severity (numeric rating scale (NRS): 0 (no pain) - 10 (worst pain imaginable)) on the first postoperative day. We want to use the so called QUIPS (quality improvement in postoperative pain management)-questionnaire for our data collection before and after introduction of the new analgesic concept. The questionnaire has been validated within a German wide benchmark project (so called QUIPS-project) and allows a comparison with other hospitals as well. Patients have to answer questions covering pain intensity, functional impairment, side effects of the medical condition or analgesic treatment and subjective global assessment. This is complemented by a part filled out by the attending physician covering relevant information about the patient, details about anaesthesia and surgery as well as analgesic score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints comprise analgesic score, treatment-related side effects, pain related functional impairment, peri- and postoperative complications and patient satisfaction. Data collection is also planned using the QUIPS-questionnaire on the 1st postoperative day. | — |
Countries
Germany
Contacts
Public ContactAntoniu-Oreste Gostian
HNO-Klinik Universitätsklinikum Erlangen
Outcome results
None listed