NCT06636578 Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block
| NCT ID | NCT06636578 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fayoum University |
| Condition | Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2024-10-10 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In 2012 Blanco et al. \[1\] described the ultrasound technique for Pectoral nerve (PECS) block as a new, less invasive regional analgesic technique for breast surgeries. PECS block includes PECS I and PECS II (modified PECS I) interfascial blocks. Since that time, PECS block has been used successfully with good results for a wide variety of surgeries on the chest wall such as radical mastectomies, breast-conserving surgeries, breast implant placement, automated implantable cardioverter-defibrillator (AICD)/pacemaker placement, intercostal drainage tube placement, and rib fractures. In this study, the investigators hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in the prolongation of the duration of anesthesia with improvement of the quality of postoperative analgesia of bilateral PECS block for patients undergoing cardiac surgery via midline sternotomy compared with using only plain ropivacaine.
Eligibility 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.
Contact & Investigator
mohamed hamed, M.D
PRINCIPAL INVESTIGATOR
Fayoum University
Frequently Asked Questions
Who can join the NCT06636578 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 65 Years, studying Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06636578 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06636578 currently recruiting?
Yes, NCT06636578 is actively recruiting participants. Contact the research team at mms12@fayoum.edu.eg for enrollment information.
Where is the NCT06636578 trial being conducted?
This trial is being conducted at Al Fayyum, Egypt, Al Fayyum, Egypt.
Who is sponsoring the NCT06636578 clinical trial?
NCT06636578 is sponsored by Fayoum University. The principal investigator is mohamed hamed, M.D at Fayoum University. The trial plans to enroll 90 participants.