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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07890857
- Acronym / sponsor ID
- Cardiac Block
- Conditions
- Cardiac Valve Disease, Coronary Heart Disease
- Keywords
- Parasternal block, Rectus sheath block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double blind controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Parasternal + rectus sheath block | Experimental | Drug: Parasternal and rectus sheath block, ropivacaine 0.25 %Participants receive a bilateral Parasternal + rectus sheath block, and multimodla analgesia |
| No block | No intervention | –No block, multimodla analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- • Participation in another study within the 30 days preceding and during the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasternal and rectus sheath block, ropivacaine 0.25 %Patients will all receive multimodal analgesia. one group will receive blocks and the other not. | Drug | Parasternal + rectus sheath block |
Primary outcome
intravenous morphine-equivalents consumption at 24 hours postoperatively
Time frame: at 24 hours postoperatively
intravenous morphine-equivalents consumption at 24 hours postoperatively, measured via iv PCA pump with (morphine 1 mg/mL)
11 secondary outcomes
postoperative pain at 2 hours
Time frame: 2 hours postoperatively
Postoperative pain at 6 hours
Time frame: 6 hours postoperatively
Postoperative pain at 12 hours
Time frame: 12 hours postoperatively
Postoperative pain at 24 hours
Time frame: 24 h postoperatively
Postoperative nausea and vomiting
Time frame: number of episodes, at 24 hours postoperatively
respiratory depression
Time frame: number of episodes, at 24 hours postoperatively
pruritus
Time frame: number of episodes, at 24 hours postoperatively
Local anesthetic systemic toxicity
Time frame: 24 hours postoperatively
Haematoma
Time frame: 24 hours postoperatively
Pneumothorax
Time frame: 24 hours postoperatively
Allergic reaction to local anaesthetic
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 32907499Cardinale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sina Grape, MD, MBA (+41276034400, sina.grape@hopitalvs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravenous morphine-equivalents consumption at 24 hours postoperatively (time frame: at 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07890857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.