ROPIVACAINE HYDROCHLORIDE for Inguinal hernia

Inclusion criteria

• {"criterion_text":"- Able to give a written informed consent\n- Aged 18 years or older at screening\n- Diagnosed with Inguinal hernia scheduled for open inguinal hernia surgery\n- Adequate Finnish language literacy\n- Unilateral surgery"}

Exclusion criteria

• {"criterion_text":"- Surgery that is planned to be performed under general or spinal anesthesia\n- Allergy or hypersensitivity to study medications or their ingredients\n- Pregnancy or breast-feeding, aim of becoming pregnant during the study,\n- Inability to provide written informed consent\n- Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study\n- A history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements\n- Prior or concurrent malignancy\n- Surgery that was not planned as day surgery\n- Bilateral surgery\n- Additional surgery to inguinal hernioplasty\n- Age under 18 years\n- Inability to give informed consent\n- Patient refusal\n- Chronic pain or prior opioid medication\n- Psychiatric disorder as defined by: medication used"}

Primary endpoints

• {"endpoint_text":"- Equivalent morphine consumption in the perioperative period and after surgery, divided in: Intraoperative period, the immediate postoperative period, defined as the time between discharge from the operating room and discharge from the hospital and seven postoperative days","definition_or_measurement_approach":"Morphine consumption measured in defined time windows: intraoperative period; immediate postoperative period (time between discharge from the operating room and discharge from the hospital); and seven postoperative days."}

Secondary endpoints

• {"endpoint_text":"- postoperative pain, as defined by numerical rating scale (NRS), patient opinion of the efficacy of the pain treatment, postoperative nausea and vomiting (PONV), as defined as use of postoperative nausea medications, use of rescue analgesia, rescue hospitalization, intra- and postoperative durations, intraoperative anesthetic methods, analysis of patient flow and, anesthesiologic and surgical complications, depression and anxiety as measured by BDI and STAI queries","definition_or_measurement_approach":"Postoperative pain measured by numerical rating scale (NRS); PONV defined as use of postoperative nausea medications; depression and anxiety measured by BDI and STAI questionnaires; other items captured as stated (patient opinion, rescue analgesia use, rescue hospitalization, durations, complications, etc.)."}

Finland

Earliest CTIS Part Ii Submission Date

03-04-2024

Latest Decision Or Authorization Date

06-11-2024

Processing Time Days

217

Number Of Sites

3

Number Of Participants

200

Primary sponsor

Full Name

Pirkanmaan hyvinvointialue

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland