Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent … (NCT05590767) | Clinical Trial Compass
CompletedNot Applicable
Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery
Taiwan40 participantsStarted 2022-10-27
Plain-language summary
When an individual encounters nociceptive pain stimuli, the pupil dilates in a unique manner known as Pupil reflex dilation (PRD).The degree of pupillary reflex dilatation can be further quantified into an objective parameter, termed the Pupillary pain index (PPI), as a monitoring tool for the balance between nociception and antinociception in surgical patients The motivation for this study is to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery. The purpose of the study is as follows: (1) Can PDR in patients undergoing general anesthesia be used to assess the analgesic effect of interscalene block? (2) Does PPI at the end of surgical anesthesia in such patients correlate with the first numerical pain scale (NRS) during the recovery room?
Who can participate
Age range
20 Years – 85 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:
* Patients who received general anesthesia combined with ipsilateral interscalene block
* Patients listed as a Class I/II physical condition of the American Society ofAnesthesiologists
Exclusion Criteria:
* Patients younger than 20 years of age
* The presence of ophthalmologic (recent eye surgery or cataracts) or neurologic diseases (diabetic neuropathy,or postherpetic neuralgia) that could interfere with Pupillometer
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Pupillary Pain Index (PPI )
Timeframe: After induction of anesthesia and before surgical incision