Hybrid Parasternal Intercostal Plane Block Versus No Block for Postoperative Analgesia After Cardiac Surgery Via Median Sternotomy
Key facts
- Who runs it
- Seo-hee Lee
- Where
- South Korea1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 172 people, planned
- Started
- 28 Oct 2026
- Expected to end
- 30 Nov 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Hybrid parasternal intercostal plane block (HPIP)
- Record updated
- 12 November 2026
Who can take part
- Age
- 19 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Adults aged 19 years or older
- Scheduled for elective cardiac surgery (e.g., valve surgery, coronary artery bypass grafting) via median sternotomy under general anesthesia
- Voluntarily provided written informed consent
Who cannot take part
- Emergency surgery or redo sternotomy
- Active infection, including sepsis
- Allergy to local anesthetics
- Cognitive impairment, delirium, inability to communicate, or inability to rate pain on the NRS
- Severe hepatic failure (Child-Pugh C) or end-stage renal disease on renal replacement therapy
- Any other condition the investigator judges to make participation inappropriate
- Contraindications to chest wall nerve block, including any of the following: warfarin use with INR not normalized to ≤ 1.4; direct oral anticoagulant taken < 24 hours before (< 48-72 hours in renal impairment); therapeutic-dose unfractionated heparin with aPTT not normalized or < 4-6 hours since the last dose; therapeutic-dose low-molecular-weight heparin < 24 hours since the last dose; clopidogrel or ticagrelor discontinued < 5 days before; thrombocytopenia (< 100,000/μL) or other clinically significant coagulopathy; local infection at the injection site
- Refusal to participate
- Chronic opioid use or opioid dependence
- Body mass index ≥ 35 kg/m²
- Pregnancy or breastfeeding
- Preoperative mechanical circulatory support (e.g., ECMO)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn whether a hybrid parasternal intercostal plane block (HPIP) reduces pain after heart surgery performed through a median sternotomy in adults. The main question it aims to answer is:
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- Does HPIP lower pain scores during coughing 12 hours after surgery compared with no block?
Researchers will also compare pain at rest, opioid use, time to first rescue pain medication, time to removal of the breathing tube, length of ICU and hospital stay, and block-related complications such as pneumothorax.
HPIP combines two ultrasound-guided chest wall nerve blocks: a superficial parasternal intercostal plane block (S-PIP) on the left side and a deep parasternal intercostal plane block (D-PIP) on the right side. This approach aims to keep the potential pain-relief benefits of the deep block while limiting its risks (such as pneumothorax and injury to the internal mammary artery) to the right side only, away from the left internal mammary artery commonly harvested for coronary bypass grafting.
Participants will:
* Be randomly assigned (1:1) to receive HPIP or no block after induction of general anesthesia and before skin incision * Receive the same standard multimodal pain management after surgery, including scheduled acetaminophen, fentanyl IV patient-controlled analgesia, and rescue pain medication as needed * Have their pain and recovery assessed by staff who do not know their group assignment
The 2 groups in the trial
- HPIP groupTreatment being tested
Patients receive an ultrasound-guided hybrid parasternal intercostal plane block (left superficial PIP + right deep PIP) after induction of general anesthesia and before skin incision, in addition to standard postoperative multimodal analgesia.
Treatment: Hybrid parasternal intercostal plane block (HPIP)
- No-block groupNo study treatment, for comparison
Patients do not receive a chest wall fascial plane block. They receive the same general anesthesia and standard postoperative multimodal analgesia (scheduled acetaminophen, fentanyl IV patient-controlled analgesia, and stepwise rescue analgesia) as the HPIP group.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Hybrid Parasternal Intercostal Plane Block Versus No Block for Postoperative Analgesia After Cardiac Surgery Via Median Sternotomy: A Randomized, Superiority Trial
- Record updated
- 12 November 2026