Opiranserin for Minimally Invasive Cholecystectomy (NCT07620665) | Clinical Trial Compass
RecruitingNot Applicable
Opiranserin for Minimally Invasive Cholecystectomy
South Korea88 participantsStarted 2026-06-10
Plain-language summary
The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy.
This is a single-center, randomized, controlled, non-inferiority clinical trial in adult patients undergoing minimally invasive cholecystectomy. Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio to compare the analgesic efficacy and safety between the two analgesic regimens.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patient undergoing minimally invasive cholecystectomy
Exclusion Criteria:
* Known hypersensitivity or allergy to acetaminophen, NSAIDs, opiranserin, or fentanyl.
* pre-existing chronic pain,
* clinically significant ECG findings (QRS \> 200 msec, QTcF \>450 msec)
* severe renal impairment
* severe hepatic impairment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a drug called opiranserin specifically for pain after laparoscopic or robotic gallbladder removal — is my planned type of cholecystectomy the right match for what this study is looking at?
2The trial is labeled 'Phase NA,' which is unusual — can you help me understand what that means for how much is already known about opiranserin's safety and effectiveness compared to a drug that has completed standard phase testing?
3The main thing this study is measuring is pain scores during the first 12 hours after surgery — does that focus on short-term pain relief align with my biggest concerns, or are there longer-term recovery outcomes I should also be thinking about?
4Since this trial is actively recruiting right now, what would my pain management look like if I don't join — is there a standard-of-care approach that might already work well for me after gallbladder surgery?
5What are the known or potential risks of opiranserin that I should weigh before deciding whether to discuss enrollment with my surgical team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the curve of the pain score at rest through 12 hours (NRS·h)