Evaluating a pain relief technique for cardiac surgery patients
Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery. A Randomized Controlled Trial
This study is testing a new pain relief technique for heart surgery patients to see if it can help them use less pain medication after their operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital du Valais Academic / other |
| Locations | 1 site (Sion) |
| Trial ID | NCT06239025 on ClinicalTrials.gov |
What this trial studies
This randomized double-blind study aims to assess the effectiveness of the Transversus Thoracis Muscle Plane Block in reducing postoperative pain in patients undergoing cardiac surgery with median sternotomy. Participants will be divided into two groups: one receiving the nerve block with ropivacaine and the other receiving standard multimodal analgesia without the block. The primary outcome will measure opioid consumption in the first 24 hours post-surgery, while secondary outcomes will include pain scores and opioid-related side effects. All procedures will be performed under general anesthesia and ultrasound guidance to ensure safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing elective primary cardiac surgery via sternotomy, who are planned for fast-track recovery.
Not a fit: Patients who may not benefit include those with severe cardiac dysfunction, previous cardiac surgeries, or allergies to ropivacaine.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid consumption in cardiac surgery patients.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques in reducing postoperative pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Informed consent * Major adult (≥ 18 years old) * Body weight ≥ 50 kg. 50 kg is the minimal weight to ensure that participants will not receive an overdose of local anesthetic (ropivacaine 3 mg/kg) * Primary cardiac surgery via a sternotomy approach * Planned for fast-track procedure (i.e. postoperative extubation time of maximum six hours) Exclusion Criteria: * • Participation in another study within the 30 days preceding and during the present study * Refusal and/or inability to understand or sign the informed consent * Emergency cardiac surgery * Previous cardiac surgery * Hypersensitivity or allergy to ropivacaine and other amide-class LA * History of chronic pain * History of substance abuse * Severe cardiac dysfunction (i.e. LVEF ≤ 35%) * Severe obesity (BMI \> 40kg/m2)
Where this trial is running
Sion
- Hopital du Valais — Sion, Switzerland (Recruiting)
Study contacts
- Study coordinator: Sina Grape, MD, MBA
- Email: sina.grape@hopitalvs.ch
- Phone: +4127603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.