Comparing two pain management techniques after heart surgery
Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study
This study is testing two different pain management techniques to see which one helps heart surgery patients use less opioid medication after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Benisuef) |
| Trial ID | NCT05627869 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two regional anesthesia techniques, the Transversus Thoracic Plane Block (TTPB) and the Pecto Intercostal Fascial Block (PIFB), in reducing opioid consumption among patients undergoing open cardiac surgery. By utilizing ultrasound-guided methods, the study seeks to minimize postoperative pain and the associated complications that arise from high-dose opioid use. The research will involve patients aged 18 to 75 who are scheduled for elective cardiac surgery, assessing their pain management outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 scheduled for elective on-pump cardiac surgery with a physical status classification of less than IV.
Not a fit: Patients undergoing emergency or off-pump surgeries, or those with chronic pain or opioid use, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced opioid consumption and improved postoperative recovery for cardiac surgery patients.
How similar studies have performed: Previous studies have shown promising results with ultrasound-guided regional anesthesia techniques, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 75 years. 2. Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy. 3. American Society of Anesthesiologists classification of physical status \< IV. Exclusion Criteria: 1. Emergency surgery. 2. Off-pump surgery. 3. Redo surgery. 4. Ejection fraction less than 35%. 5. Refusal of the patient. 6. Known hypersensitivity to LA. 7. Chronic opioid use or chronic pain patient. 8. Psychiatric problems or communication difficulties. 9. Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7) 10. Renal insufficiency (defined as a glomerular filtration rate \< 44 ml/min). 11. Obstructive sleep apnea syndrome. 12. Coexisting hematologic disorders. 13. Pregnancy or breastfeeding.
Where this trial is running
Benisuef
- Benisuef University Hospital — Benisuef, Egypt (Recruiting)
Study contacts
- Principal investigator: Mariana A Mansour, Lecturer — Benisuef university hospital
- Study coordinator: Mariana A Mansour, lecturer
- Email: mrmrsyk4@gmail.com
- Phone: 01222960009
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.