Analgesic EffectPhase 4PAINCARENCT06369870

Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy

A Phase 4 study testing Levobupivacaine Hydrochloride 0.25 % Injectable Solution and Sodium chloride 0.9% in people with Analgesic Effect, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Analgesic Effect
What is being tested?: Levobupivacaine Hydrochloride 0.25 % Injectable Solution and Sodium chloride 0.9%
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 144 participants
Where: 1 siteBelgium
Study dates: 1 Sep 2024to Mar 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

Adult patients (18 years of age or older);
Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy;
Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV;
Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%;
Patient has given written, free and informed consent.

Who cannot join

BMI > 35;
Patients under legal protection (curatorship, guardianship);
Patients subject to a legal protection measure;
An adult who is incapable or unable to give consent;
Patients requiring emergency surgery within 24 hours;
Chronic opioid use (> 3 administrations per week or continuous transdermal therapy, longer than the last 3 months);

Show all 19Show fewer

Patients known with chronic pain;
Patients known with an allergy to levobupivacaine or drugs used as standard of care, including amongst others piritramide, dexamethasone, propofol, remifentanil, rocuronium, acetaminophen, ondansetron;
Patients who receive medication that could possibly interact with levobupivacaine (mexiletine, ketoconazole, theophylline);
Patients who took monoamine oxidase (MAO) inhibitors within the last 2 weeks before surgery;
Patients with chronic renal failure (dialysis dependent, estimated glomerular filtration rate (eGFR) < 30 ml.min-1.(1,73 m²)-1) ;
Patients with severe hepatic impairment (Model for End-Stage Liver Disease (MELD) score ≥ 20);
Patients with preoperative cognitive dysfunction (Mini Mental State Examination (MMSE) score < 24);
Patients with uncontrolled epilepsy;
Patients with severe arterial hypotension (Systolic Arterial Pressure (SAP) < 90 mmHg, cardiogenic shock);
Patients who simultaneously participate in another interventional clinical trial;
Soft tissue infection in the area of the procedure;
Patients who are pregnant, parturient or breast-feeding women;
Patients who are unable to sufficiently speak and write in the Dutch language.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bart Vaes, MD contact

0032 9 246 17 00

bart.vaes@mijnziekenhuis.be

Ella Hermie, MSc contact

0032 9 246 17 03

ella.hermie@mijnziekenhuis.be

Belgium1 site, 1 recruiting

AZ Maria Middelares
Ghent, East-Flanders, 9000
Bart Vaes, MD, 00329 246 17 00, ella.hermie@mijnziekenhuis.be
Ella Hermie, MSc, 00329 246 17 03, ella.hermie@mijnziekenhuis.be
Recruiting

Other trials in Belgium

About this study

Official title: Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy: a Single Centre, Prospective, Double-blind, Randomized Controlled Superiority Trial

The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery.

Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups.

Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

Read the detailed description

This clinical trial aims to evaluate the analgesic effect of an interpectoral-pectoserratus plane (IPP-PSP) block compared to a placebo (sham block) in patients undergoing aortic valve replacement via right anterior minithoracotomy (AVR-RAT). The primary objective is to determine whether the IPP-PSP block effectively reduces opioid consumption during the first 28 hours post-surgery.

The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. It will enroll adult patients aged 18 years or older who are scheduled for minimally invasive AVR-RAT and meet specific inclusion criteria. Exclusion criteria are established to ensure the safety and integrity of the trial.

Patients undergoing minimally invasive AVR-RAT will be randomly assigned to either the IPP-PSP block group or the sham block group.

The primary endpoint of the trial is the cumulative opioid consumption (in oral morphine milligram equivalents (OMEs)) within the first 48 postoperative hours after completion of the surgical procedure. Secondary outcomes include the number of episodes of postoperative pain, time to need for rescue medication, incidence of respiratory complications, PaCO2 levels, postsurgical recovery, episodes of postoperative nausea and vomiting, time to extubation in the Intensive Care Unit (ICU), ICU length of stay, hospital length of stay, quality of life, number of days alive and at home after surgery, and vital status at 30 days post-operative.

The trial aims to enroll a total of 144 patients, with 72 patients randomized into each group. Blinding will be implemented, meaning neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment.

The anesthesia and monitoring proceed as usual for such procedures. After the anesthesiologist administered the IPP-PSP block or a placebo at the end of the procedure, the participant will be transferred to the ICU. During the hospital stay, they will be regularly asked to assess their pain level, and additional pain relief will be administered, if necessary.

To assess quality of recovery and quality of life differences between groups, participants will complete two questionnaires the day before surgery. A recovery questionnaire will be completed at three time points post-surgery (day 1, day 2, and day 7 after the surgery). Participants will be involved in the trial for a total of 31 days, with follow-up during hospitalization and a follow-up phone call 30 days post-surgery.

Conditions: Analgesic Effect
Being tested: Levobupivacaine Hydrochloride 0.25 % Injectable Solution, Sodium chloride 0.9%
Keywords: interpectoral-pectoserratus plane block, aortic valve replacement via right anterior minithoracotomy, IPP-PSP block, AVR-RAT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levobupivacaine Hydrochloride 0.25 % Injectable SolutionDrug
Also called IPP-PSP block, Intervention group
After wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).
Sodium chloride 0.9%Drug
Also called Sham block, Control group
Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the intervention description of the IPP-PSP block.

Study groups in NCT06369870
Study group	Role	What they receive
Levobupivacaine Hydrochloride 0.25 % Injectable Solution	Active comparator	Unilateral (right) IPP-PSP block with 30 mL levobupivacaine 0.25%, administered after the closure of the wounds. After wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP). Receives: Drug: Levobupivacaine Hydrochloride 0.25 % Injectable Solution
Sodium chloride 0.9%	Sham comparator	Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the Active Comparator. Receives: Drug: Sodium chloride 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative opioid consumption
Cumulative opioid consumption (in oral morphine milligram equivalents (OMEs)) in the first 48 postoperative hours after the completion of the surgical procedure
Measured: in the first 48 hours after completion of the surgical procedure

Secondary outcomes (12)

Number of episodes of postoperative pain
Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 48 postoperative hours after the completion of the surgical procedure
Measured: In the first 48 hours after completion of the surgical procedure
Time to need for rescue medication
Time to need for rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hours after the completion of the surgical procedure (minutes)
Measured: In the first 48 hours after completion of the surgical procedure
Number of patients with respiratory complications
Number of patients with 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
Measured: During hospital stay (on average 7 days)
PaCO2 levels
Levels of arterial partial pressure of carbon dioxide (PaCO2) measured every 4 hours during the 48 postoperative hours after the completion of the surgical procedure or until Intensive Care Unit (ICU) discharge, whichever occurs first
Measured: During the 48 postoperative hours after the completion of the surgical procedure or until Intensive Care Unit (ICU) discharge, whichever occurs first;
Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire
Postsurgical recovery by Quality of Recovery questionnaire (QoR-15NL) on day before (D-1), first (D1), second (D2) and seventh (D7) day after surgery.
The minimum score on the Quality of Recovery questionnaire is 0 and the maximum score 150. Higher scores mean better quality of recovery.
Measured: Day before, first, second and seventh day after surgery
Number of episodes of postoperative nausea and vomiting
Number of episodes of postoperative nausea and vomiting (PONV) in the first 48 postoperative hours after the completion of the surgical procedure: nausea yes/no, vomiting: yes/no
Measured: Number of episodes of postoperative nausea and vomiting (PONV) in the first 48 postoperative hours after the completion of the surgical procedure: nausea yes/no, vomiting: yes/no
Time to extubation
Time to extubation of the patient in the Intensive Care Unit
Measured: Minutes (assessed up to 6 hours after surgery)
Number of hours spent in the Intensive Care Unit
Number of hours spent in the Intensive Care Unit (until ready for discharge)
Measured: Hours (on average 48 hours)
Hospitalization duration
Number of days in the hospital between surgery and first hospital discharge
Measured: Days (on average 7 days)
Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire
The quality of life by the EQ-5D-5L questionnaire on the day before surgery and 30 days (D30) after surgery.
The minimum health utility value of the Belgian EQ-5D-5L value set is -0.532 and the maximum value 1 in Belgium. Higher utility scores mean better health related quality of life.
Measured: Day before and 30 days after surgery
Days alive and at home
Number of days alive and at home after surgery (DAH30)
Measured: 30 (+7) days after surgery
Vital status (whether the patient is alive or dead)
Vital status at 30 days after surgery
Measured: 30 (+7) days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 2024Mar 2028

First posted17 Apr 2024
Study start1 Sep 2024
Primary completionFeb 2028 (estimated)
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Analgesic EffectStudies 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: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 144 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06369870
Sponsor's protocol ID: PAINCARE
Acronym: PAINCARE
Status last verified: Oct 2026
First submitted: 8 Apr 2024
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Bart Vaes, MD

0032 9 246 17 00

bart.vaes@mijnziekenhuis.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Analgesic Effect trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy: a Single Centre, Prospective, Double-blind, Randomized Controlled Superiority Trial
ClinicalTrials.gov ID: NCT06369870
Acronym / sponsor ID: PAINCARE / PAINCARE
Conditions: Analgesic Effect
Keywords: interpectoral-pectoserratus plane block, aortic valve replacement via right anterior minithoracotomy, IPP-PSP block, AVR-RAT
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 144 participants (estimated)
Lead sponsor: Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
Study start: 1 Sep 2024 (actual)
Primary completion: Feb 2028 (estimated)
Study completion: Mar 2028 (estimated)
First posted: 17 Apr 2024 (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.

Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery.

Detailed description

Patients undergoing minimally invasive AVR-RAT will be randomly assigned to either the IPP-PSP block group or the sham block group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo).

Arm	Type	Receives
Levobupivacaine Hydrochloride 0.25 % Injectable Solution	Active comparator	Drug: Levobupivacaine Hydrochloride 0.25 % Injectable SolutionUnilateral (right) IPP-PSP block with 30 mL levobupivacaine 0.25%, administered after the closure of the wounds. After wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).
Sodium chloride 0.9%	Sham comparator	Drug: Sodium chloride 0.9%Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. Unilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the Active Comparator.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult patients (18 years of age or older);
Patients scheduled for minimally invasive aortic valve replacement via right anterior minithoracotomy;
Patients with American Society of Anesthesiologists (ASA) physical status classification II, III or IV;
Patients with European System for Cardiac Operative Risk Evaluation (EuroSCORE) 2 ≤ 4%;
Patient has given written, free and informed consent.

Key exclusion criteria (19 listed)

BMI > 35;
Patients under legal protection (curatorship, guardianship);
Patients subject to a legal protection measure;
An adult who is incapable or unable to give consent;
Patients requiring emergency surgery within 24 hours;

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
Levobupivacaine Hydrochloride 0.25 % Injectable SolutionAlso: IPP-PSP block, Intervention groupAfter wound closure, the IPP-PSP block is performed at the level of the 4th rib. At the pre-axillary line, the pectoralis major, the pectoralis minor and the serratus anterior muscle are identified. At first, the needle is positioned in the fascial plane between the pectoralis minor and the serratus anterior muscle. The needle position is confirmed by hydro-dissection of this plane with 2 mL of normal saline 0.9%.The 20 ml syringe with trial drug solution is injected in this pectoserratus plane (PSP). The needle tip is repositioned in the interpectoral plane between both the pectoralis major and minor muscle. The 10 ml syringe with trial drug solution is administered in this interpectoral plane (IPP).	Drug	Levobupivacaine Hydrochloride 0.25 % Injectable Solution
Sodium chloride 0.9%Also: Sham block, Control groupUnilateral (right) IPP-PSP block with 30 mL normal saline 0.9%, administered after the closure of the wounds. The IPP-PSP block procedure will be carried out as described in the intervention description of the IPP-PSP block.	Drug	Sodium chloride 0.9%

Primary outcome

Cumulative opioid consumption
Time frame: in the first 48 hours after completion of the surgical procedure
Cumulative opioid consumption (in oral morphine milligram equivalents (OMEs)) in the first 48 postoperative hours after the completion of the surgical procedure

12 secondary outcomes

Number of episodes of postoperative pain
Time frame: In the first 48 hours after completion of the surgical procedure
Time to need for rescue medication
Time frame: In the first 48 hours after completion of the surgical procedure
Number of patients with respiratory complications
Time frame: During hospital stay (on average 7 days)
PaCO2 levels
Time frame: During the 48 postoperative hours after the completion of the surgical procedure or until Intensive Care Unit (ICU) discharge, whichever occurs first;
Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire
Time frame: Day before, first, second and seventh day after surgery
Number of episodes of postoperative nausea and vomiting
Time frame: Number of episodes of postoperative nausea and vomiting (PONV) in the first 48 postoperative hours after the completion of the surgical procedure: nausea yes/no, vomiting: yes/no
Time to extubation
Time frame: Minutes (assessed up to 6 hours after surgery)
Number of hours spent in the Intensive Care Unit
Time frame: Hours (on average 48 hours)
Hospitalization duration
Time frame: Days (on average 7 days)
Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire
Time frame: Day before and 30 days after surgery
Days alive and at home
Time frame: 30 (+7) days after surgery
Vital status (whether the patient is alive or dead)
Time frame: 30 (+7) days after surgery

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 28 Oct 2026.

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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.

Bart Vaes, MD contact

0032 9 246 17 00

bart.vaes@mijnziekenhuis.be

Ella Hermie, MSc contact

0032 9 246 17 03

ella.hermie@mijnziekenhuis.be

Bart Vaes, MD principal investigator

Algemeen Ziekenhuis Maria Middelares

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 28 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 Belgium. 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. Some participants in this study may receive a placebo. 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 Bart Vaes, MD (0032 9 246 17 00, bart.vaes@mijnziekenhuis.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative opioid consumption (time frame: in the first 48 hours after completion of the surgical procedure). 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 NCT06369870.

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 28 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.