Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT01122693
Eligibility Criteria:
Inclusion Criteria:
* Patients at the age of 18 and above who need a regional anesthesia catheter for postoperative pain management after elective orthopedic surgery
Exclusion Criteria:
* Participation in another trial according to the German Drug Law 30 days to and during the study
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* (Unclear) history of alcohol or substances disabuse
* Absent knowledge of German language
* Analphabetism
* Allergy to local anesthesia or other ingredients of the intravenous solutions
* For women: Pregnancy or positive pregnancy test within the preoperative screening
* Operation due to case of emergency, polytrauma or pathologic fracture
* American Society of Anaesthesiologists (ASA) classification greater than III
* Peripheral or central edema
* AIDS (according to the CDC-classification of HIV-infection: category C)
* Immunosuppression therapy
* History of bleeding tendency (e.g. von-Willebrand-disease, thrombocytopenia)
* Derailed metabolic disorder (e.g. Diabetes mellitus (Glucose \> 300 mg/dl) during the preoperative screening)
* Known history of electrolyte disturbance (e.g. Hyperkalemia \> 5.8 mmol/l, Hypernatraemia \> 155 mmol/l)
* Known history of acid-base-dysbalances
* History of intracranial hemorrhage within one year of participation in the study
* Neurological or psychiatric disease with limited contractual capability
* CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV
* Liver disease (CHILD B or C cirrhosis, end-stage liver disease (MELD-score greater than 10)
* Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01122693
Study Brief:
Protocol Section:
NCT01122693