Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
136
Countries
1
Sites
2
Patients undergoing cardiac surgery through conventional median sternotomy access
To investigate the efficacy of a bilateral superficial parasternal intercostal plane (SPIP) block in the postoperative recovery of patients undergoing cardiac surgery via conventional median sternotomy.
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 14 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy, Efficacy
To investigate the efficacy of a bilateral superficial parasternal intercostal plane (SPIP) block in the postoperative recovery of patients undergoing cardiac surgery via conventional median sternotomy.
Secondary objectives 1
- To investigate the impact on postoperative opioid consumption, pain scores and opioid related side effects.
Conditions and MedDRA coding
Patients undergoing cardiac surgery through conventional median sternotomy access
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10021415 | Immediate postoperative analgesia | 10042613 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening During screening written informed consent will be obtained, inclusion & exclusion criteria will be checked, demographic data and vital signs will be recorded. Baseline questionnaires (QoR-15NL, EQ-5D-5L and BPI) will be obtained.
|
Not Applicable | None | ||
| 2 | Randomization Patient's eligibility criteria will be checked. Patient will be randomised by an unblinded member of the study team, not invloved in patient care. Patiens will be randomised in two groups
|
Randomised Controlled | Double | [{"id":144710,"code":5,"name":"Carer"},{"id":144712,"code":2,"name":"Investigator"},{"id":144711,"code":1,"name":"Subject"}] | SPIP: The bilateral SPIP block with 40 mL trial drug solution is administered after skin closure. The trial drug solution contains ropivacaine, dosed according to the corresponding weight category, which is diluted with normal saline to a total volume of 40 mL. The trial drug solution volume will be divided into two 20 mL syringes. The labelling of the syringes will not display information in regard to the study medication it may contain nor the allocated treatment arm. After skin closure, the bilateral SPIP block will be performed by the (sub)-investigator with the use of a linear, high-frequency ultrasound probe. Ultrasound images of each separate LA administration will be stored. The SPIP block is first performed on the left hemithorax. At the level of the 2nd intercostal space (ICS), 2-3 cm lateral to the sternal bone, the pectoralis major muscle (PMM) and the external intercostal muscle (exIM) are identified. The needle is positioned in the fascial plane between the PMM and the exIM, and correct positioning is confirmed by hydro-dissection of this fascial plane with 2 mL of normal saline 0.9%. In this fascial plane, 6 ml trial drug solution is injected. Consecutively, this is repeated at the 4th and 5th ICS, administering 7 mL of trial drug solution at these sites. This exact procedure is replicated on the right hemithorax. Control: The bilateral SPIP block with 40 mL Normal saline 0.9% is administered after skin closure. The 40 ml Normal saline 0.9% will be divided into two 20 mL syringes. The labelling of the syringes will not display information in regard to the study medication it may contain nor the allocated treatment arm. After skin closure, the bilateral SPIP block will be performed by the (sub)-investigator with the use of a linear, high-frequency ultrasound probe. Ultrasound images of each separate LA administration will be stored. The SPIP block is first performed on the left hemithorax. At the level of the 2nd intercostal space (ICS), 2-3 cm lateral to the sternal bone, the pectoralis major muscle (PMM) and the external intercostal muscle (exIM) are identified. The needle is positioned in the fascial plane between the PMM and the exIM, and correct positioning is confirmed by hydro-dissection of this fascial plane with 2 mL of normal saline 0.9%. In this fascial plane, 6 ml trial drug solution is injected. Consecutively, this is repeated at the 4th and 5th ICS, administering 7 mL of trial drug solution at these sites. This exact procedure is replicated on the right hemithorax. |
| 3 | Follow-up 3h-6h-12h post operative pain scores will be checked
Postoperative day 1 -2 and 3: pain scores will be checked, patient will be asked to complete QoR-15 and EQ-5D-5L questionnaires;
30 day post surgery: completion of the EQ-5D-5L questionnaire during phone call
|
Not Applicable | Double | [{"id":144716,"code":2,"name":"Investigator"},{"id":144715,"code":1,"name":"Subject"},{"id":144714,"code":5,"name":"Carer"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form
- Patients scheduled for cardiac surgery via conventional median sternotomy.
- Patients with an European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 3 %.
- Dutch speaking
Exclusion criteria 8
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- BMI > 35
- Patients with a bodyweight below 50 kg or exceeding 95 kg.
- An adult who is incapable or unable to give consent (e.g. curatorship, guardianship, language barrier,…).
- Patients requiring emergency surgery within 24 hours.
- Patients with chronic pain (i.e., chronic opioid use or other analgesics)
- 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
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 10
- The cumulative opioid consumption in the first 72 hours after surgical incision
- Time to first rescue analgesia for breakthrough pain (e.g. oxycodone or piritramide) in the first 72 hours after surgical incision (in minutes).
- 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.
- 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.
- Number of patients with PONV in the first 24 hours after surgical incision
- Time spent in the ICU/PACU until fit for discharge (in hours).
- Time spent in the hospital between surgical incision and the first hospital discharge (in hours).
- 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
- QoR-15NL score on the second (D2) after surgery
- EQ-5D-5L score 30 days after surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Naropin® 7,5 mg/ml Amp. 20 ml Injektionslösung
PRD12295015 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 240 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 37101.01.00
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
MINI-PLASCO NACL B. BRAUN 0,9 %, oplossing voor injectie
PRD5424751 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 40 ml millilitre(s)
- Max total dose
- 40 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- BE119016
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Danny Hoogma
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Danny Hoogma
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 136 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-11-14 | 2025-11-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522135-34 | 2 |
| Protocol (for publication) | D4_Patient facing document QoR-15 questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing documents EQ-5D-5L Belgium- Dutch questionnaire | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1 |
| Subject information and informed consent form (for publication) | L_Informed consent procedure | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF STAR Dutch version | 1 |
| Subject information and informed consent form (for publication) | L1_sponsor statement | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ropivacaine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ENG DUT FR GER 2025-522135-34 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-22 | Belgium | Acceptable 2025-09-26
|
2025-10-01 |