Deep Parasternal Intercostal Plane Block

NCT ID: NCT06895876

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2025-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Deep parasternal intercostal plane block

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

Group Type EXPERIMENTAL

Deep parasternal intercostal plane block

Intervention Type PROCEDURE

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

Control

Standard multimodal analgesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep parasternal intercostal plane block

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients requiring cardiac surgery with sternotomy

Exclusion Criteria

* Emergency procedure
* Procedures requiring lateral chest drainage
* Hemodynamic instability
* Severe kidney or liver failure
* BMI \> 40
* Chronic pain
* Allergy to local anesthesics
* Pregnant woman
* Long term opioïds use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute Arnault Tzanck, France

OTHER

Sponsor Role lead

Responsible Party

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Marc LOPEZ, MD

Investigator principal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institut Arnault Tzanck

Saint-Laurent-du-Var, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 9175983 (View on PubMed)

Mangano 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.

Reference Type BACKGROUND
PMID: 1531742 (View on PubMed)

Aydin 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.

Reference Type BACKGROUND
PMID: 32665179 (View on PubMed)

Other Identifiers

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2021-A01183-38

Identifier Type: -

Identifier Source: org_study_id

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