- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06895876
Deep Parasternal Intercostal Plane Block (DPIP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint-Laurent-du-Var, France, 06700
- Institut Arnault Tzanck
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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
|
|
No Intervention: Control
Standard multimodal analgesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption at 24 hours
Time Frame: 24 hours after surgery
|
Total morphine consumption, in milligrams, during the first 24 hours after surgery.
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-A01183-38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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