Efficacy of Bilateral Superficial Parasternal Intercostal Plane Block with Ropivacaine Hydrochloride in Postoperative Recovery of Cardiac Surgery Patients

The primary objective is to evaluate the efficacy of a bilateral superficial parasternal intercostal plane block in enhancing postoperative recovery for patients undergoing cardiac surgery via median sternotomy.
Secondary objectives include the assessment of:

• Postoperative opioid consumption, pain scores, and opioid-related side effects.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients undergoing cardiac surgery through conventional median sternotomy access. Included individuals are both male and female, aged within specific age range codes, and are Dutch speaking. Eligible participants must have a EuroSCORE II between 2% and 3%. Participation requires the provision of voluntary written informed consent by the individual or a legally authorized representative.

This multicentric, double-blind, prospective, randomized controlled superiority trial evaluates the efficacy of a bilateral superficial parasternal intercostal plane block in patients undergoing cardiac surgery via conventional median sternotomy. Participants are randomized to receive either a test intervention consisting of ropivacaine hydrochloride or a placebo containing sodium chloride administered via perineural use. The primary outcome is the mean difference in the Dutch Quality of Recovery 15 items questionnaire score on the first postoperative day. Secondary endpoints include cumulative opioid consumption, time to first rescue analgesia, Numerical Rating Scale scores, occurrence of postoperative nausea and vomiting, and length of stay in the intensive care unit or hospital. The study procedure involves a screening phase to confirm eligibility based on age, language, and EuroSCORE II parameters, followed by the surgical intervention and subsequent follow-up assessments, including a 30-day evaluation using the EQ-5D-5L score. The trial is estimated to occur between October 2025 and September 2027.

The experimental treatment consists of ropivacaine hydrochloride, administered as a solution for injection. The total dose is 240 mg, delivered via perineural use.

The control group receives a placebo consisting of sodium chloride in a solution for injection. The administered volume is 40 ml via perineural use.

The primary efficacy endpoint is the mean difference in the QoR-15NL score between the intervention group receiving a bilateral superficial parasternal intercostal plane block and the control group receiving a placebo. This assessment is performed on the first postoperative day, defined as 24 hours following surgical incision, utilizing the Dutch Quality of Recovery 15 items questionnaire.

Secondary efficacy parameters include:

• Cumulative opioid consumption during the first 72 hours after surgical incision.
• Time to first rescue analgesia for breakthrough pain, such as oxycodone or piritramide, within the first 72 hours post-incision, measured in minutes.
• The area under the curve (AUC) of reported dynamic NRS scores at predefined timepoints of 3, 6, 12, 24, 48, and 72 hours during the first 72 hours after surgical incision.
• The number of patients experiencing postoperative nausea and vomiting (PONV) within the first 24 hours after surgical incision.
• Duration of time spent in the intensive care unit (ICU) or post-anesthesia care unit (PACU) until the patient is fit for discharge, and the total time in the hospital between surgical incision and the first hospital discharge, both measured in hours.
• The occurrence of respiratory complications requiring non-invasive ventilation (NIV), high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours, or orotracheal re-intubation.
• The QoR-15NL score on the second postoperative day.
• The EQ-5D-5L score at 30 days after surgery.