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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT06387303
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
* Undergoing laparotomy with midline incision
* Body mass index (BMI) between 18.5 and 45
* Ability to understand and read English
* Willingness and ability to comply with scheduled visits and study procedures
Exclusion Criteria:
* Not able or unwilling to sign consent
* Patients undergoing ambulatory surgery or anticipated to be discharged sooner than 24 hours after surgery
* Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as the FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin.
* Pregnant Women
* Patients requiring emergent surgery
* Contraindications to neuraxial anesthesia including:
* Coagulopathy
* localized infection at the site of injection
* pre-existing spinal pathology, specifically defined as active radiculopathy, severe central canal stenosis in the lumbar region, or an acute fracture in the lumbar region
* length of the QT interval (QTc) \>450 on the most recent preoperative electrocardiogram (EKG)
* Prior spinal fusion
* Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06387303
Study Brief:
Protocol Section:
NCT06387303