Pain SyndromePEPSNCT04546113
Erector Spinae Plane Block Versus Paravertebral Block for Analgesia After Cardiac Surgery (PEPS)
A study testing Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side and Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side in people with Pain Syndrome and Analgesia, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Syndrome, Analgesia, Anesthesia, Local
- What is being tested?
- Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side and Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2021to 2 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy
- Physical status classification (ASA) ≤3
- Patients benefiting from a Social Security scheme or benefiting from it through a third party
Who cannot join
- Emergency cardiac surgery
- Exclusion criteria related to cardiac surgery with thoracotomy, occurrence of aortic dissection, redo surgery.
- Aortic counterpulsation
- Preoperative cardiogenic shock
- LVEF< 30%
- Severe preoperative chronic or acute renal failure with creatinine clearance less than 30 mL / min according to the MDRD formula
Show all 12Show fewer
- Pre-existing psychiatric pathology, including addiction to opioids
- Physical or intellectual incapacity to use a PCA
- Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opioids)
- Contraindication for performing the paravertebral block and Erector of the spine (ESP): Infection at the site of injection, severe hemostasis disorder, thoracic spinal pathology making the procedure difficult or dangerous to operate
- Obese patient (BMI> 30kg / m2) with poorly perceived thoracic spinous processes.
- vulnerable patients(Pregnant or breastfeeding women, persons benefiting from enhanced protection, namely persons deprived of their liberty by a judicial or administrative decision, adults under legal protection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.
The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.
Read the detailed description
Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine.
Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation.
Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia.
During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB.
Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.
- Conditions
- Pain Syndrome, Analgesia, Anesthesia, Local
- Being tested
- Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side, Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side
- Keywords
- Cardiac surgery, Regional analgesia, Pain control
- Medical subject headings
- Somatoform Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/sideProcedure or surgery
Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side
Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/sideProcedure or surgery
Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block | Active comparator | If the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB after induction of general anesthesia. The patient is positioned in lateral decubitus position. The anesthetist performs the bilateral paravertebral block with ultrasound identification of the paravertebral space at the T4-T5 level. Slow injection of 0.3 to 0.35 ml / kg of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of NaCl 0.9%) after aspiration test. Receives: Procedure: Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side |
| Erector Spinae Plane Block | Experimental | If the patient is randomized to group "Erector Spinae Plane Block", the anesthesiologist performs the ESPb block after induction of general anesthesia. The patient is positioned in a right lateral decubitus position. The anesthesiologist performs the erector block of the spine ESP with ultrasound identification at the T4-T5 level (identify the 1st rib on ultrasound then the space T4 to T5). Slow injection of 20 ml of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of 0.9% NaCl) after aspiration test.
The patient is then turned in left lateral decubitus position and the contralateral block is performed according to the same procedure. Receives: Procedure: Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Pain assessment measured with Visual Analogue Scale (VAS) between 0 (no pain, best outcome) and 10 (worst possible pain, worst outcome) at mobility, (respiratory effort during peak flow meter measurement)
Measured: 6 hours from the end of the surgery
Secondary outcomes (8)
Efficacy of the block (a)
Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)
Measured: During the surgery
Efficacy of the block (b)
Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia))
Measured: During the surgery
Efficacy of the block (c)
Based on hemodynamic response to incision and sternotomy (increase in blood pressure, measured in mmHg). Blood pressure numbers of less than 120/80 mm Hg are considered within the normal range.
Measured: During the surgery
Intraoperative sufentanil consumption
Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml.
Measured: During the surgery
Postoperative pain assessment
Pain assessment measured with Visual Analogue Scale between 0 (no pain, best outcome) and 10 (worst possible pain and and worst outcome) at mobility, (respiratory effort during peak flow meter measurement)
Measured: 3, 6, 12, 24, 48 hours from the end of the surgery
Postoperative Morphine consumption
Morphine PCA consumption, measured in mg/h.
Measured: 3, 6, 12, 24, 48 hours from the end of the surgery
Side effects associated to morphine
Incidence of post operative nausea, vomiting and sedation
Measured: 3, 6, 12, 24, 48 hours from the end of the surgery
Complication(s) associated to the procedure
Pneumothorax, major hematoma, sympathetic block
Measured: 48 hours from the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start7 Jan 2021
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
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 Pain SyndromeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Responsible party
- Sponsor
- Investigators
- Olivier MONTANDRAU, MD, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546113
- Sponsor's protocol ID
- ANEST-03-2019
- Acronym
- PEPS
- Status last verified
- Mar 2025
- First submitted
- 22 Jul 2020
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Montandrau O, Kattou F, Arana H, Rekik M, Ait Hamou N, Weisslinger SJ, Teil E, Mekaouar S, Bargaoui A, Bouattour K, Bey Boumezrag C, Lacombe JM, Lebatard N, Zannis K, Beaussier M. Ultrasound-guided thoracic paravertebral block versus erector spinae plane block analgesia for cardiac surgery with median sternotomy: a noninferiority randomised controlled trial. Br J Anaesth. 2026 Feb;136(2):687-694. doi: 10.1016/j.bja.2025.10.039. Epub 2025 Nov 24.
PubMed 41290467
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT04546113
- Acronym / sponsor ID
- PEPS / ANEST-03-2019
- Conditions
- Pain Syndrome, Analgesia, Anesthesia, Local
- Keywords
- Cardiac surgery, Regional analgesia, Pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 11 Sep 2020 (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 purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.
Detailed description
Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine.
Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation.
Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia.
During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB.
Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block | Active comparator | Procedure: Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/sideIf the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB after induction of general anesthesia. The patient is positioned in lateral decubitus position. The anesthetist performs the bilateral paravertebral block with ultrasound identification of the paravertebral space at the T4-T5 level. Slow injection of 0.3 to 0.35 ml / kg of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of NaCl 0.9%) after aspiration test. |
| Erector Spinae Plane Block | Experimental | Procedure: Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/sideIf the patient is randomized to group "Erector Spinae Plane Block", the anesthesiologist performs the ESPb block after induction of general anesthesia. The patient is positioned in a right lateral decubitus position. The anesthesiologist performs the erector block of the spine ESP with ultrasound identification at the T4-T5 level (identify the 1st rib on ultrasound then the space T4 to T5). Slow injection of 20 ml of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of 0.9% NaCl) after aspiration test. The patient is then turned in left lateral decubitus position and the contralateral block is performed according to the same procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy
- Physical status classification (ASA) ≤3
- Patients benefiting from a Social Security scheme or benefiting from it through a third party
Key exclusion criteria (12 listed)
- Emergency cardiac surgery
- Exclusion criteria related to cardiac surgery with thoracotomy, occurrence of aortic dissection, redo surgery.
- Aortic counterpulsation
- Preoperative cardiogenic shock
- LVEF< 30%
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 |
|---|---|---|
| Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/sideBilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side | Procedure or surgery | Paravertebral Block |
| Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/sideBilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Pain assessment
Time frame: 6 hours from the end of the surgery
Pain assessment measured with Visual Analogue Scale (VAS) between 0 (no pain, best outcome) and 10 (worst possible pain, worst outcome) at mobility, (respiratory effort during peak flow meter measurement)
8 secondary outcomes
Efficacy of the block (a)
Time frame: During the surgery
Efficacy of the block (b)
Time frame: During the surgery
Efficacy of the block (c)
Time frame: During the surgery
Intraoperative sufentanil consumption
Time frame: During the surgery
Postoperative pain assessment
Time frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Postoperative Morphine consumption
Time frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Side effects associated to morphine
Time frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Complication(s) associated to the procedure
Time frame: 48 hours from the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 41290467Montandrau O, Kattou F, Arana H, Rekik M, Ait Hamou N, Weisslinger SJ, Teil E, Mekaouar S, Bargaoui A, Bouattour K, Bey Boumezrag C, Lacombe JM, Lebatard N, Zannis K, Beaussier M. Ultrasound-guided thoracic paravertebral block versus erector spinae plane block analgesia for cardiac surgery with median sternotomy: a noninferiority randomised controlled trial. Br J Anaesth. 2026 Feb;136(2):687-694. doi: 10.1016/j.bja.2025.10.039. Epub 2025 Nov 24.
- 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. This study is not recruiting at the moment.
Olivier MONTANDRAU, MD principal investigator
Institut Mutualiste Montsouris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of Ropivacaine 3,75 mg/ml/side and Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side in people with Pain Syndrome and Analgesia, run by Institut Mutualiste Montsouris at 1 site in France.
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 12 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: finished, as of the sponsor's last update on 18 Mar 2025. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 6 hours from the end of the surgery). 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 NCT04546113, 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 18 Mar 2025.