Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT05627869
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05627869
Study Brief:
Protocol Section:
NCT05627869