NCT06895876

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

March 4, 2022

Last Update Submit

May 1, 2026

Conditions

Nerve Block

Keywords

Transversus thoracic muscle plane blockCardiac surgeryPostoperative analgesiaQuality of recoveryQoR-15

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours after surgery

Secondary Outcomes (1)

  • Total morphine consumption at 24 hours

    24 hours after surgery

Study Arms (2)

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

Procedure: Deep parasternal intercostal plane block

Control

NO INTERVENTION

Standard multimodal analgesia

Interventions

Deep parasternal intercostal plane blockPROCEDURE

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

Deep parasternal intercostal plane block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring cardiac surgery with sternotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Arnault Tzanck

Saint-Laurent-du-Var, 06700, France

Location

Related Publications (3)

  • 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.

    PMID: 9175983BACKGROUND

  • 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.

    PMID: 1531742BACKGROUND

  • 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.

    PMID: 32665179BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator principal

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 26, 2025

Study Start

August 10, 2022

Primary Completion

October 12, 2022

Study Completion

June 15, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations

FR(1)