Postoperative PainNCT07614607
Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial
A study testing Opioid Analgesic and automated pupillometry in people with Postoperative Pain and Postoperative Pain Management, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Postoperative Pain Management
- What is being tested?
- Opioid Analgesic and automated pupillometry
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
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.
Read more
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.
- Conditions
- Postoperative Pain, Postoperative Pain Management
- Being tested
- Opioid Analgesic, automated pupillometry
- Keywords
- pupillometry, automated pupillometry, post-operative pain, post-operative opiod consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid AnalgesicDrug
Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline after induction. The automated pupillometry measurement is repeated 5 mins after increment. Prior to skin closing, IV morphine 0.1 mg/kg during skin closing and automated pupillometry measurement is repeated to aim pupillary diameter is within 20% of baseline. Analgesics is titrated according to the anaesthetist's discretion and reason is documented if it is deviated from the protocol.
automated pupillometryDevice
For both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins.
For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Participants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml, titrated according to the anaesthetist's discretion. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. Additional analgesics could be administered as control arm.
At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.Anaesthetists will give rescue morphine when the pupillary diameter changes > 20% and repeat the measurement after 5 minutes Receives: Drug: Opioid Analgesic; Device: automated pupillometry |
| Control | Other | Participants in the control group will receive anaesthetic and analgesic management as per the standard practice followed by the attending anaesthetist. Additional analgesics, including intravenous paracetamol, intravenous parecoxib, and abdominal plane blocks, will be provided if there are no contraindications. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min. Receives: Device: automated pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative opioid consumption
the amount of post operative opioid consumption including rescue analgesia and patient controlled analgesia morphine usage would be recorded
Measured: first 24 hours post operatively
Secondary outcomes (1)
The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
To find the measurement changes or correlation with opioiod administration, and to analyse it statistically
Measured: automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 May 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, pragmatic, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEAP CHUN HONG, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614607
- Sponsor's protocol ID
- 202541314965
- Other IDs
- BKP004-2025-ECRG
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Utility of the Automated Pupillometer in Pain Assessment and Opioid Administration Guidance During the Perioperative Period: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07614607
- Acronym / sponsor ID
- 202541314965
- Conditions
- Postoperative Pain, Postoperative Pain Management
- Keywords
- pupillometry, automated pupillometry, post-operative pain, post-operative opiod consumption
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective, pragmatic, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Opioid Analgesic, Device: automated pupillometryParticipants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml, titrated according to the anaesthetist's discretion. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. Additional analgesics could be administered as control arm. At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min.Anaesthetists will give rescue morphine when the pupillary diameter changes > 20% and repeat the measurement after 5 minutes |
| Control | Other | Device: automated pupillometryParticipants in the control group will receive anaesthetic and analgesic management as per the standard practice followed by the attending anaesthetist. Additional analgesics, including intravenous paracetamol, intravenous parecoxib, and abdominal plane blocks, will be provided if there are no contraindications. Automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision and during skin closure. At the post anaesthesia recovery area, PLR will be measured at 10 min and at 30 min. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid AnalgesicParticipants in the interventional group will receive an initial dose of 100 mcg IV fentanyl during induction. Remifentanil will be administered via effect-site target-controlled infusion (TCI), with a concentration effect (Ce) ranging from 2 to 8 ng/ml. TCI remifentanil is increased by 0.5 ng/ml if pupillary diameter changes > 20% of the baseline after induction. The automated pupillometry measurement is repeated 5 mins after increment. Prior to skin closing, IV morphine 0.1 mg/kg during skin closing and automated pupillometry measurement is repeated to aim pupillary diameter is within 20% of baseline. Analgesics is titrated according to the anaesthetist's discretion and reason is documented if it is deviated from the protocol. | Drug | Intervention |
| automated pupillometryFor both arms, automated pupillometry will be measured before induction , after induction(baseline), before the surgical incision, after surgical incision, during skin closure, at PACU 10 mins and at PACU 30 mins. For intervention arm only, the additional automated pupillometry measurement will be performed after administration of analgesia. | Device | Control, Intervention |
Primary outcome
post operative opioid consumption
Time frame: first 24 hours post operatively
the amount of post operative opioid consumption including rescue analgesia and patient controlled analgesia morphine usage would be recorded
1 secondary outcome
The correlation between pupillary response metrics (% change, constriction velocity, dilatation velocity, NPi) and opioid dosage administered.
Time frame: automated pupillometry measurements will be done before induction, after induction, before skin incision, during skin incision, after skin incision, during skin closure, and at post anaesthesia recovery unit 10 min and 30 min.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Analgesic and automated pupillometry in people with Postoperative Pain and Postoperative Pain Management, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative opioid consumption (time frame: first 24 hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.