ROPIVACAINE HYDROCHLORIDE for Periacetabular osteotomy

Inclusion criteria

• {"criterion_text":"- Patients ≥ 18 years old\n- Informed consent\n- Scheduled for periacetabular osteotomy under general anesthesia with intubation\n- American Society of Anesthesiologists (ASA) physical status classification I to III\n- Can read and understand Danish"}

Exclusion criteria

• {"criterion_text":"- Known allergy to ropivacaine\n- Daily use of opioids, gabapentin or tricyclic antidepressant (regardless of dose) within the last four weeks prior to surgery\n- Contraindications to Celocoxib, NSAIDs or paracetamol"}

Primary endpoints

• {"endpoint_text":"- Area under curve (AUC) of pain reported on a numeric rating scale (NRS) from 0 to 10 during the first 24 hours postoperatively","definition_or_measurement_approach":"Pain reported on a numeric rating scale (NRS) from 0 to 10; AUC calculated during the first 24 hours postoperatively"}

Secondary endpoints

• {"endpoint_text":"- The number of patients reporting moderate to severe pain at rest [>3 out of 10 on a numeric rating scale (NRS) from 0 to 10] at any point in the immediate postoperative phase (from arrival at the PACU until transfer to the ward). NRS will be assessed upon arrival at the PACU and each 30 minutes.","definition_or_measurement_approach":"NRS assessed upon arrival at the PACU and every 30 minutes; count of patients reporting NRS >3 at any point in immediate postoperative phase (arrival at PACU until transfer to ward)"}
• {"endpoint_text":"- Pain during during mobilization (from laying down in bed till standing on the floor) assessed on a NRS at 5 hours after extubation","definition_or_measurement_approach":"NRS assessment at 5 hours after extubation during mobilization (from lying in bed until standing and walking 5 meters)"}
• {"endpoint_text":"- Opioid use from tracheal extubation until 24 hours postoperatively","definition_or_measurement_approach":"Measurement of opioid consumption from tracheal extubation until 24 hours postoperatively"}

Denmark

Earliest CTIS Part Ii Submission Date

05-06-2024

Latest Decision Or Authorization Date

25-06-2024

Processing Time Days

20

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"Sponsor duties code: 1","organisation_type":"Health care"}