Ropivacaine hydrochloride for Postoperative pain after cardiac surgery (median sternotomy)

Stratification factors

• hospital

Inclusion criteria

• {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n- At least 18 years of age at the time of signing the Informed Consent Form\n- Patients scheduled for cardiac surgery via conventional median sternotomy.\n- Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 3 %.\n- Dutch speaking"}

Exclusion criteria

• {"criterion_text":"- Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n- BMI > 35\n- Patients with a bodyweight below 50 kg or exceeding 95 kg.\n- An adult who is incapable or unable to give consent (e.g. curatorship, guardianship, language barrier,…).\n- Patients requiring emergency surgery within 24 hours.\n- Patients with chronic pain (i.e., chronic opioid use or other analgesics)\n- Any disorder or medical condition, which in the principle investigator’s opinion, would jeopardise the patient’s safety or compliance with the trial. (allergies, concomitant drugs that interact with the IMP\n- If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. Women of child-bearing potential (WOCBP) should only be included after a confirmed menstrual period and urinary pregnancy test. Participants are considered not of childbearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal, defined as no menses for 12 months without an alternative medical cause."}

Primary endpoints

• {"endpoint_text":"- The primary outcome is the mean difference in QoR-15NL score between the verum bilateral SPIP block (intervention group) and the placebo bilateral SPIP block (control group) in patients undergoing cardiac surgery via conventional median sternotomy on the first postsurgical day, defined as 24 hours after surgical incision, assessed by the Dutch Quality of Recovery 15 items questionnaire.","definition_or_measurement_approach":"Mean difference in QoR-15NL score between intervention and placebo groups at 24 hours after surgical incision, measured using the Dutch Quality of Recovery 15-item questionnaire."}

Secondary endpoints

• {"endpoint_text":"- The cumulative opioid consumption in the first 72 hours after surgical incision","definition_or_measurement_approach":"Total opioid consumption recorded over the first 72 hours after surgical incision (units and aggregation method as per protocol)."}
• {"endpoint_text":"- Time to first rescue analgesia for breakthrough pain (e.g. oxycodone or piritramide) in the first 72 hours after surgical incision (in minutes).","definition_or_measurement_approach":"Time in minutes from surgical incision to first administration of rescue analgesia within the first 72 hours."}
• {"endpoint_text":"- The AUC of the reported dynamic NRS scores at predefined timepoints (assessed at 3, 6, 12, 24, 48, 72 hours) during the first 72 hours after surgical incision.","definition_or_measurement_approach":"Area under the curve (AUC) of dynamic Numeric Rating Scale (NRS) pain scores measured at 3, 6, 12, 24, 48 and 72 hours post incision."}
• {"endpoint_text":"- The AUC of the reported dynamic NRS scores at predefined timepoints (assessed at 3, 6, 12, 24, 48, 72 hours) during the first 72 hours after surgical incision.","definition_or_measurement_approach":"Duplicate endpoint entry in source; same AUC of dynamic NRS scores as above."}
• {"endpoint_text":"- Number of patients with PONV in the first 24 hours after surgical incision","definition_or_measurement_approach":"Count of patients experiencing postoperative nausea and vomiting (PONV) within 24 hours after surgical incision."}
• {"endpoint_text":"- Time spent in the ICU/PACU until fit for discharge (in hours).","definition_or_measurement_approach":"Number of hours from ICU/PACU admission until patient judged fit for discharge from ICU/PACU."}
• {"endpoint_text":"- Time spent in the hospital between surgical incision and the first hospital discharge (in hours).","definition_or_measurement_approach":"Number of hours from surgical incision until first hospital discharge."}
• {"endpoint_text":"- Occurrence of respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation","definition_or_measurement_approach":"Incidence of respiratory complications defined by need for NIV, HFNC, or prolonged/repeated orotracheal intubation."}
• {"endpoint_text":"- QoR-15NL score on the second (D2) after surgery","definition_or_measurement_approach":"Quality of Recovery 15-item Dutch questionnaire score assessed on postoperative day 2."}
• {"endpoint_text":"- EQ-5D-5L score 30 days after surgery","definition_or_measurement_approach":"EQ-5D-5L health-related quality of life score collected 30 days after surgery (phone call)."}

Belgium

Earliest CTIS Part Ii Submission Date

09-05-2025

Latest Decision Or Authorization Date

01-10-2025

Processing Time Days

145

Number Of Sites

2

Number Of Participants

136

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium