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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT04046068
Eligibility Criteria:
Inclusion Criteria:
1. Be between the ages of 21 and 75 years of age.
2. Be eligible to receive bupivacaine liposomal injectable suspension.
3. Be undergoing a planned inpatient surgical (breast, caesarian-section or abdominal) procedure with general anesthesia.
4. Provide an opioid-free urine prior to surgical procedure.
5. Have a supportive, significant other willing to facilitate patient adherence to ComfortSafe program
6. Be agreeable to study procedures and capable of signing an informed consent.
Exclusion Criteria:
1. Be on chronic opioid therapy for chronic pain or treatment of opioid use disorder.
2. Have chronic pain.
3. Have an active substance use disorder on alcohol, benzodiazepine, methamphetamine, cocaine or other drugs of abuse (except nicotine).
4. Be acutely psychotic, severely depressed and in need of inpatient treatment, or an immediate suicide risk.
5. Have a neurological or psychiatric illness (i.e., schizophrenia, quadriplegia, stroke) that would affect pain responses.
6. Be undergoing a surgical procedure for which liposomal bupivacaine cannot be used (eg. Skin graft, wound debridement, ureteroscopy, hysteroscopy, eye surgery).
7. Have a diagnosis of Obstructive Sleep Apnea with use of CPAP
8. Have an ASA score of 2 or greater as determined by the anesthesiologist.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT04046068
Study Brief:
Protocol Section:
NCT04046068