LEVOBUPIVACAINE for Colorectal cancer

Inclusion criteria

• {"criterion_text":"- Patients > 18 years old."}
• {"criterion_text":"- Scheduled for laparoscopic colorectal cancer surgery (right hemicolectomy, left hemicolectomy, total colectomy, abdominoperineal resection of the rectum, low or ultra-low anterior resection of the rectum)."}

Exclusion criteria

• {"criterion_text":"- •\tUrgent colorectal cancer surgery."}
• {"criterion_text":"- Allergy to local anesthetics."}
• {"criterion_text":"- Patient refusal to undergo analgesic techniques."}
• {"criterion_text":"- Patient refusal to participate in the study."}
• {"criterion_text":"- BMI > 35 or < 50 kg."}
• {"criterion_text":"- Chronic opioid therapy"}
• {"criterion_text":"- Communication difficulties due to language barrier or pathology."}

Primary endpoints

• {"endpoint_text":"- Pain intensity measured with the visual analog scale (VAS),","definition_or_measurement_approach":"Pain intensity measured with the visual analog scale (VAS)"}

Secondary endpoints

• {"endpoint_text":"- Consumption of minor and major opioids during admission: The milligrams of minor (tramadol) and major (morphine) opioids administered to the patient will be recorded. Data collection times will be the same as for the VAS, at 2, 6, 24, and 48 hours after surgery completio","definition_or_measurement_approach":"The milligrams of minor (tramadol) and major (morphine) opioids administered to the patient will be recorded. Data collection times at 2, 6, 24, and 48 hours after surgery."}
• {"endpoint_text":"- Incidence of postoperative nausea and vomiting","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

01-08-2024

Latest Decision Or Authorization Date

03-09-2024

Processing Time Days

33

Number Of Sites

1

Number Of Participants

174

Primary sponsor

Full Name

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain