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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT02828059
Eligibility Criteria:
Inclusion Criteria:
* Elective or emergent Caesarean section under spinal or general anesthesia
* Medically indicated necessity of post-surgery analgesia
* Signed informed consent
* Body Mass Index above 20 and below 35
Exclusion Criteria:
* Wound drainage application following surgery
* Epidural catheter following surgery
* Planned concurrent surgical Intervention
* Chronic high-dose opioid use (\>20 mg oxycodone equivalent daily) over more than 4 weeks prior to surgery
* History of, suspected or present addiction or abuse of illicit drug(s), prescription medicine(s) or alcohol during the preceding 2 years
* Intolerance or allergy to any of the medications planned for use
* Concurrent painful physical conditions that may require analgesic Treatment
* Current or planned administration of Long-acting Opioids, selective Serotonin reuptake Inhibitors, gabapentin, pregabalin or duloxetine within 30 days preceding and7or following surgery
* Use of systemic glucocorticoids (except for induction of fetal lung maturation) within 1 month prior to enrollment
* Uncontrolled anxiety, schizophrenia or other psychiatric conditions which could interfere with the compliance and subjective assessment of Treatment effects (decision at the discretion of the investigator)
* Inability to operate devices for Patient-controlled analgesia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02828059
Study Brief:
Protocol Section:
NCT02828059