Active — Not RecruitingNot Applicable

Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial

Malaysia68 participantsStarted 2026-05-01

Plain-language summary

Effective intraoperative and postoperative pain management is critical for patient comfort and recovery, yet traditional methods for assessing pain under general anaesthesia are limited by their subjective nature and reliance on vital signs. Automated pupillometry, which gives the parameters of the pupillary light reflex (PLR) components, offers an objective and quantitative approach to evaluating nociception and pain. This study aims to evaluate the effectiveness of the automated pupillometry in enhancing early postoperative pain control and to assess its utility in guiding opioid administration during the perioperative period. A prospective, non-blinded randomized controlled trial will be conducted with 68 patients undergoing laparotomy for gastrointestinal surgery. Participants will be randomly assigned to either an interventional group, where analgesia is guided by automated pupillometry measurements, or a control group receiving standard pain management. Key outcomes include the time to first rescue analgesia, self-reported pain scores, opioid consumption. The automated pupillometry measurements will be taken at key surgical moments, including before induction, pre-incision, and during recovery. Pain scores and rescue analgesia use will be compared between groups using appropriate statistical tests, and Kaplan-Meier survival curves will analyze time to first rescue analgesia. Regression analyses will explore the relationship between pupillometry readings and postoperative pain. It is anticipated that the automated pupillometry guided group will experience longer intervals before requiring rescue analgesia and report lower pain scores, suggesting improved pain management and reduced opioid use. This study could validate automated pupillometry as an innovative tool for optimizing postoperative pain management, potentially improving patient outcomes by enabling more precise and effective analgesia in surgical settings.

Who can participate

Age range

18 Years – 70 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: * 1\. Patients aged 18 - 70 years old scheduled for elective/emergency laparotomy with clear awareness and good communication * 2\. ASA (American Society of Anaesthesiologists) physical status I-III * 3\. Expected to have moderate to severe pain in the early postoperative period Exclusion Criteria: * 1\. Patient with known pupillary abnormality (such as anisocoria, pharmacologic dilation, previous intraocular surgery) * 2\. Pre-existing neurological disorder affecting pupillary reflexes * 3\. Patients on chronic opioid therapy or with a history of substance abuse * 4\. Non-consenting patients or those with cognitive impairments affecting informed consent

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

post operative opioid consumption

Timeframe: first 24 hours post operatively

Trial details

NCT IDNCT07614607

SponsorUniversity of Malaya

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Postoperative Pain trials