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 @ 5:21 PM
Ignite Modification Date:
2025-12-24 @ 5:21 PM
NCT ID:
NCT07254650
Eligibility Criteria:
Inclusion Criteria:
* Plan to undergo planned (elective) minimally invasive isolated R-VATS procedure, to include pulmonary anatomic resections (anatomic lobectomy, segmentectomy, and wedge resection if performed robotically)
* Age ≥ 18 years old
* Ability to understand and capacity/willingness to sign a written informed consent form
Exclusion Criteria:
* Age \< 18 years old
* Unwilling to sign informed consent form, mentally challenged/delayed, or lacking capacity/unable to consent to participation in the trial own their own behalf
* Vulnerable populations
* Incarcerated individuals
* Pregnant individuals
* Breastfeeding individuals
* Individuals with potentially altered pharmacokinetics and metabolism of study drugs
* Renal failure: creatinine ≥ 2, or glomerular filtration rate \< 45 mL/min
* Hepatic failure: serum ammonia \> 33 mcg/dL and/or Child-Pugh \> A
* Individuals suffering from chronic pain
* Individuals taking pre-operative narcotics
* Patients undergoing emergent surgery or urgent surgery for acute, traumatic injuries
* Patients undergoing extra-pleural resections, chest wall resection, pleurectomies, pleurodesis, and decortications
* Planned concurrent abdominal procedure: for example, but not limited to, an esophagectomy
* Patients requiring subcostal transversus abdominis plane (TAP) block
* Use of a rib spreader during thoracic procedure
* Patients admitted to the intensive care unit (ICU) post-operatively while sedated and intubated
* Patients with major post-operative complications
* Wedge resection for pulmonary bleb
* Unanticipated pleurectomy, even if partial
* Surgeon injects superficial wounds with LipoB
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07254650
Study Brief:
Protocol Section:
NCT07254650