Can a Pre-Incision pain pump transform heart surgery recovery?
NCT ID NCT04495504
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial tests whether placing thin catheters alongside the breastbone before a heart surgery incision and delivering the numbing drug ropivacaine can reduce pain after the operation. Adults under 85 having planned heart surgery through a sternotomy may receive this continuous local anesthetic for the first 48 hours after surgery. The goal is to see if this method keeps pain scores low and reduces the need for opioid painkillers, potentially improving comfort and shortening recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ropivacaine
- What this could lead to
- If effective, this approach could reduce pain and opioid use after heart surgery, potentially speeding recovery and shortening hospital stays.
- What could go wrong
- The trial is small and early, so results may not apply broadly. Risks include catheter-related complications or inadequate pain relief.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
32 people
The number who actually took part.
- Started
-
Jul 2020
- Finished
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Jul 2021
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery * Age under 85 years * Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code * Possession of Social Security insurance. Exclusion Criteria: * Emergency surgery * Approach by thoracotomy * Heart transplant * Aortic dissection * Redo surgery. * Pregnant women * Refusal of the protocol * Protected minors or adults * Pre-existing psychiatric pathology including known states of opioid addiction * Long-term opioid medication * Physical or intellectual inability to use a PCA * Severe heart failure (ejection fraction less than 40% or PAH \> 50 mmHg) * Preoperative cardiogenic shock * Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula * Known hypersensitivity to local anesthetics or to any component of the catheter * Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire
Clermont-Ferrand, Puy de Dôme, 63000, France
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