Nerve BlockDPIPNCT06895876
Deep Parasternal Intercostal Plane Block
A study testing Deep parasternal intercostal plane block in people with Nerve Block, run by Institute Arnault Tzanck, France at 1 site in France.
Trial summary
Cardiac surgery is a source of severe post operative pain witch can cause major respiratory complications due to non optimal post operative rehabilitation. Multimodal analgesia provides acceptable pain control , but does not seem sufficient during coughing or mobilization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- Deep parasternal intercostal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 10 Aug 2022to 15 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring cardiac surgery with sternotomy
Who cannot join
- Emergency procedure
- Procedures requiring lateral chest drainage
- Hemodynamic instability
- Severe kidney or liver failure
- BMI > 40
- Chronic pain
Show all 9Show fewer
- Allergy to local anesthesics
- Pregnant woman
- Long term opioïds use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Parasternal Intercostal Plane Block : Effect on the Quality of Postoperative Recovery After Cardiac Surgery
Cardiac surgery is a source of severe post operative pain witch can cause major respiratory complications due to non optimal post operative rehabilitation.
Multimodal analgesia provides acceptable pain control , but does not seem sufficient during coughing or mobilization. The use of morphine also exposes patients to side effects (nausea, vomiting, pruritus, respiratory depression, chronic pain, ileus). Bleeding and hemodynamic risks of peridural and spinal aneshesia limits their use.
The postoperative efficacy of deep parasternal intercostal plane block has not yet been evaluated sufficiently. The aim of this study is to evaluate the efficacity of TTMPB on the quality of postoperative recovery after cardiac surgery.
- Conditions
- Nerve Block
- Being tested
- Deep parasternal intercostal plane block
- Keywords
- Transversus thoracic muscle plane block, Cardiac surgery, Postoperative analgesia, Quality of recovery, QoR-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep parasternal intercostal plane blockProcedure or surgery
The block is performed bilaterally in the 4th intercostal space. The probe is placed in the latero-median axis and a needle is placed latero-medially between the intercostal and transverse thoracic muscle. The solution is then injected under ultrasound control
| Study group | Role | What they receive |
|---|---|---|
| Deep parasternal intercostal plane block | Experimental | The block is performed bilaterally in the 4th intercostal space. The probe is placed in the latero-median axis and a needle is placed latero-medially between the intercostal and transverse thoracic muscle. The solution is then injected under ultrasound control ()20 mL of 0,375% Naropeïne Receives: Procedure: Deep parasternal intercostal plane block |
| Control | No intervention | Standard multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 15 (QoR-15)
QoR-15 score : 0 to 150. Addition of 15 items note between 0 to 10 150 = perfect post operative recovery possible 0 = worst post operative recovery possible
Measured: 24 hours after surgery
Secondary outcomes (1)
Total morphine consumption at 24 hours
Total morphine consumption, in milligrams, during the first 24 hours after surgery.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start10 Aug 2022
- Primary completion12 Oct 2022
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute Arnault Tzanck, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc LOPEZ, MD, Institute Arnault Tzanck, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895876
- Sponsor's protocol ID
- 2021-A01183-38
- Acronym
- DPIP
- Status last verified
- May 2026
- First submitted
- 4 Mar 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
PubMed 9175983Mangano DT, Siliciano D, Hollenberg M, Leung JM, Browner WS, Goehner P, Merrick S, Verrier E. Postoperative myocardial ischemia. Therapeutic trials using intensive analgesia following surgery. The Study of Perioperative Ischemia (SPI) Research Group. Anesthesiology. 1992 Mar;76(3):342-53.
PubMed 1531742Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
PubMed 32665179
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Parasternal Intercostal Plane Block : Effect on the Quality of Postoperative Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06895876
- Acronym / sponsor ID
- DPIP / 2021-A01183-38
- Conditions
- Nerve Block
- Keywords
- Transversus thoracic muscle plane block, Cardiac surgery, Postoperative analgesia, Quality of recovery, QoR-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Institute Arnault Tzanck, FranceUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 26 Mar 2025 (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.
Cardiac surgery is a source of severe post operative pain witch can cause major respiratory complications due to non optimal post operative rehabilitation.
Multimodal analgesia provides acceptable pain control , but does not seem sufficient during coughing or mobilization. The use of morphine also exposes patients to side effects (nausea, vomiting, pruritus, respiratory depression, chronic pain, ileus). Bleeding and hemodynamic risks of peridural and spinal aneshesia limits their use.
The postoperative efficacy of deep parasternal intercostal plane block has not yet been evaluated sufficiently. The aim of this study is to evaluate the efficacity of TTMPB on the quality of postoperative recovery after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep parasternal intercostal plane block | Experimental | Procedure: Deep parasternal intercostal plane blockThe block is performed bilaterally in the 4th intercostal space. The probe is placed in the latero-median axis and a needle is placed latero-medially between the intercostal and transverse thoracic muscle. The solution is then injected under ultrasound control ()20 mL of 0,375% Naropeïne |
| Control | No intervention | –Standard multimodal analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring cardiac surgery with sternotomy
Key exclusion criteria (9 listed)
- Emergency procedure
- Procedures requiring lateral chest drainage
- Hemodynamic instability
- Severe kidney or liver failure
- BMI > 40
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 |
|---|---|---|
| Deep parasternal intercostal plane blockThe block is performed bilaterally in the 4th intercostal space. The probe is placed in the latero-median axis and a needle is placed latero-medially between the intercostal and transverse thoracic muscle. The solution is then injected under ultrasound control | Procedure or surgery | Deep parasternal intercostal plane block |
Primary outcome
Quality of recovery 15 (QoR-15)
Time frame: 24 hours after surgery
QoR-15 score : 0 to 150. Addition of 15 items note between 0 to 10 150 = perfect post operative recovery possible 0 = worst post operative recovery possible
1 secondary outcome
Total morphine consumption at 24 hours
Time frame: 24 hours after 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 7 May 2026.
- Background: PubMed 9175983Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.
- Background: PubMed 1531742Mangano DT, Siliciano D, Hollenberg M, Leung JM, Browner WS, Goehner P, Merrick S, Verrier E. Postoperative myocardial ischemia. Therapeutic trials using intensive analgesia following surgery. The Study of Perioperative Ischemia (SPI) Research Group. Anesthesiology. 1992 Mar;76(3):342-53.
- Background: PubMed 32665179Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
- Individual participant dataSharing planned: Undecided
Related trials for Nerve Block
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Active, not recruitingPhase 2
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma
RecruitingPhase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
Intractable Pain, Palliative Care
Enrolling by invitationPhase 4
Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)
Wrist Fracture
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep parasternal intercostal plane block in people with Nerve Block, run by Institute Arnault Tzanck, France 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 1 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: finished, as of the sponsor's last update on 7 May 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 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?
Quality of recovery 15 (QoR-15) (time frame: 24 hours after 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 NCT06895876, which also lists 3 linked publications.
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 7 May 2026.