Comparing dexmedetomidine and plain ropivacaine for pain relief after heart surgery
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block for Fast Tracking and Postoperative Analgesia in Open Heart Surgery Through Midline Sternotomy. A Randomized Clinical Trial
This study is testing if adding dexmedetomidine to ropivacaine can help patients feel less pain and have longer-lasting anesthesia after heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Fayoum University Academic / other |
| Locations | 2 sites (Al Fayyum and 1 other locations) |
| Trial ID | NCT06636578 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adding dexmedetomidine to ropivacaine in bilateral pectoralis nerve blocks for patients undergoing cardiac surgery via midline sternotomy. The study is a double-blind randomized controlled trial conducted at Fayoum University Hospital, where eligible patients will receive either the combination of dexmedetomidine and ropivacaine or plain ropivacaine alone. The aim is to determine if the addition of dexmedetomidine prolongs anesthesia duration and improves postoperative analgesia. Patients will be carefully monitored for hemodynamic stability and other health parameters before the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 65 years with an ejection fraction greater than 35% scheduled for elective isolated coronary artery bypass grafting (CABG) or valve surgery.
Not a fit: Patients with poor left ventricular function, recent myocardial infarction, or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance pain management and recovery for patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown promising results with the use of PECS blocks for analgesia in various chest surgeries, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 20 - 65 years, * Ejection fraction (EF) \> 35%, * Elective isolated CABG, or Valve surgery Exclusion Criteria: * Poor left ventricular function with intra-aortic balloon pump support, * Recent myocardial infarction (last seven days), * Combined procedure (i.e., CABG + other heart/vascular procedure), * Emergency surgery, or Redo cases, * Hepatic or renal failure, creatinine \>1.5, * Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.
Where this trial is running
Al Fayyum and 1 other locations
- Fayoum University Hospital — Al Fayyum, Egypt (Completed)
- Mohamed Hamed — Al Fayyum, Egypt (Recruiting)
Study contacts
- Principal investigator: mohamed hamed, M.D — Fayoum University
- Study coordinator: mina fam, M.D
- Email: mms12@fayoum.edu.eg
- Phone: 01025273637
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.