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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04503720
Eligibility Criteria:
Inclusion Criteria:
* Planned for elective or urgent# open abdominal surgery
Abdominal Surgery may include the following procedures:
A) Urgent laparotomy for perforated viscus, intestinal obstruction. B) Elective abdominal surgery for upper and lower gastrointestinal surgery
* Ability to provide informed consent. A signed and dated written informed consent prior to study participation.
* Age 21 to 80 years for both males and females
Exclusion Criteria:
* Female subject who is pregnant
* Inability to comply with PCA instructions due to physical disabilities. For example, visual or hearing impairment, arthritis, peripheral neuropathy.
* Known allergy to local anaesthetic or opioid drugs (Morphine).
* Current or recent on opioid therapy. For example due to chronic pain illness, opioid (or other) drug abuse or recent surgery.
* Severe comorbid diseases including liver cirrhosis, renal failure requiring dialysis, Grade 4 NYHA (New Yoke Heart Association) heart failure, respiratory illness requiring NIV (Non-Invasive Ventilation), etc.
* Severe associated acute illness American Society of Anesthesiologists (ASA) Grade 4 or 5 where survival following surgery is not expected
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04503720
Study Brief:
Protocol Section:
NCT04503720