Cardiac Valve DiseasePhase 4NCT07890857
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
A Phase 4 study testing Parasternal and rectus sheath block, ropivacaine 0.25 % in people with Cardiac Valve Disease and Coronary Heart Disease, run by Hôpital du Valais at 1 site in Switzerland.
Trial summary
The investigators will examine whether the combination of a superficial parasternal block and rectus sheath block with multimodal analgesia can enhance postoperative pain control and reduce opioid administration when compared to multimodal analgesia alone, in participants undergoing cardiac surgery and receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Disease, Coronary Heart Disease
- What is being tested?
- Parasternal and rectus sheath block, ropivacaine 0.25 %
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2026to 30 Nov 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight ≥ 50 kg.
- Primary cardiac surgery via a median sternotomy approach
- Planned for fast-track procedure (i.e. postoperative extubation time of maximum six hours)
Who cannot join
- • Participation in another study within the 30 days preceding and during the present study
- Emergency cardiac surgery
- Previous cardiac surgery
- Hypersensitivity or allergy to ropivacaine and other amide-class LA
- History of chronic pain
- History of substance abuse
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- Renal dysfunction (i.e. creatinine clearance ≤ 30 ml/min)
- Severe cardiac dysfunction (i.e. LVEF ≤ 35%)
- Severe obesity (BMI > 40 kg/m2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
CHVR
Sion, Valais, 1950
Sina Grape, MD, MBA, +41276034400, sina.grape@hopitalvs.ch
Adrien Gross, MD, +41276031979, adrien.gross@hopitalvs.ch
About this study
Official title: Efficacy of Superficial Parasternal Block Combined With Rectus Sheath Block in Patients Undergoing Cardiac Surgery With Sternotomy A Randomized Controlled, Double Blind Trial (Cardiac Block Trial)
The investigators will examine whether the combination of a superficial parasternal block and rectus sheath block with multimodal analgesia can enhance postoperative pain control and reduce opioid administration when compared to multimodal analgesia alone, in participants undergoing cardiac surgery and receiving standardized multimodal analgesia.
Read the detailed description
In this randomized double blind study the investigators aim to examine whether the combination of a superficial parasternal block and rectus sheath block with multimodal analgesia can enhance postoperative pain control and reduce opioid administration when compared to multimodal analgesia alone, in participants undergoing cardiac surgery with midline sternotomy. All blocks will be administered at the end of surgery.
Multimodal analgesia is inclusive of: sufentanil, paracetamol, metamizol, dexamethasone, magnesium sulfate. all patients are aimes for fast track surgery, i.e. extubation within 6 hours after the end of the intervention.
The hypothesis of the investigators is that combining rectus sheath block and parasternal block will reduce postoperative pain during the first 24 postoperative hours after cardiac surgery, when compared to a standard multimodal analgesic regimen alone.
- Conditions
- Cardiac Valve Disease, Coronary Heart Disease
- Being tested
- Parasternal and rectus sheath block, ropivacaine 0.25 %
- Keywords
- Parasternal block, Rectus sheath block
- Medical subject headings
- Heart Valve Diseases, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal and rectus sheath block, ropivacaine 0.25 %Drug
Patients will all receive multimodal analgesia. one group will receive blocks and the other not.
| Study group | Role | What they receive |
|---|---|---|
| Parasternal + rectus sheath block | Experimental | Participants receive a bilateral Parasternal + rectus sheath block, and multimodla analgesia Receives: Drug: Parasternal and rectus sheath block, ropivacaine 0.25 % |
| No block | No intervention | No block, multimodla analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravenous morphine-equivalents consumption at 24 hours postoperatively
intravenous morphine-equivalents consumption at 24 hours postoperatively, measured via iv PCA pump with (morphine 1 mg/mL)
Measured: at 24 hours postoperatively
Secondary outcomes (11)
postoperative pain at 2 hours
Numeric Rating Scale (NRS), minimum = 0 (no pain), maximum = 10 (worst pain imaginable)
Measured: 2 hours postoperatively
Postoperative pain at 6 hours
Numeric Rating Scale (NRS), minimum = 0 (no pain), maximum = 10 (worst pain imaginable)
Measured: 6 hours postoperatively
Postoperative pain at 12 hours
Numeric rating scale, minimum = 0 (no pain), maximum = 10 (worst pain imaginable)
Measured: 12 hours postoperatively
Postoperative pain at 24 hours
Numeric rating scale, minimum = 0 (no pain), maximum = 10 (worst pain imaginable)
Measured: 24 h postoperatively
Postoperative nausea and vomiting
Postoperative nausea and vomiting
Measured: number of episodes, at 24 hours postoperatively
respiratory depression
respiratory depression
Measured: number of episodes, at 24 hours postoperatively
pruritus
pruritus
Measured: number of episodes, at 24 hours postoperatively
Local anesthetic systemic toxicity
occurence of Local anesthetic systemic toxicity (yes/no)
Measured: 24 hours postoperatively
Haematoma
occurence of haematoma at puncture site (yes/no)
Measured: 24 hours postoperatively
Pneumothorax
occurence of pneumothorax (yes/no)
Measured: 24 hours postoperatively
Allergic reaction to local anaesthetic
occurence of allergy (yes/no)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890857
- Sponsor's protocol ID
- Cardiac Block
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cardinale JP, Latimer R, Curtis C, Bukovskaya Y, Kosarek L, Falterman J, Tatum DM, Trusheim J. Incorporation of the Transverse Thoracic Plane Block Into a Multimodal Early Extubation Protocol for Cardiac Surgical Patients. Semin Cardiothorac Vasc Anesth. 2021 Dec;25(4):301-309. doi: 10.1177/1089253220957484. Epub 2020 Sep 9.
PubMed 32907499