PainNCT03103360
Pupillary Pain Index and Reaction to Skin Incision
An observational study of Pain and Anesthesia, run by Pr Isabelle CONSTANT at 1 site in France.
Trial summary
During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pain, Anesthesia, Surgery
- What is being tested?
- videopupillometer and skin incision
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2018to 2 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under general anesthesia for an elective or emergent surgery requiring a skin incision in a body area not covered by regional anesthesia
Who may be able to join
- patient requiring general anesthesia
- surgical procedure involving a skin incision
- no regional anesthesia
- written informed consent
Who cannot join
- neurologic or ophthalmic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia
During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.
- Conditions
- Pain, Anesthesia, Surgery
- Being tested
- videopupillometer, skin incision
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videopupillometerDevice
Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds
skin incisionProcedure or surgery
performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between pre-incision pupillary pain index and post-incision heart rate increase
Measured: 4 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision blood pressure increase
Measured: 4 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision bispectral index increase
Measured: 4 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision movement occurrence
Measured: 4 minutes: one minute before incision, 3 minutes after incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start2 May 2018
- Primary completion2 Nov 2019
- Study completion2 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Isabelle CONSTANT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Isabelle Constant, MD-PHD, Study director, University Hospital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103360
- Sponsor's protocol ID
- PPI incision
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2017
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03103360
- Acronym / sponsor ID
- PPI incision
- Conditions
- Pain, Anesthesia, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Pr Isabelle CONSTANTUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 2 Nov 2019 (actual)
- Study completion
- 2 Nov 2019 (actual)
- First posted
- 6 Apr 2017 (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.
During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under general anesthesia for an elective or emergent surgery requiring a skin incision in a body area not covered by regional anesthesia
Key inclusion criteria (4 listed)
- patient requiring general anesthesia
- surgical procedure involving a skin incision
- no regional anesthesia
- written informed consent
Key exclusion criteria (1 listed)
- neurologic or ophthalmic disease
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 |
|---|---|---|
| videopupillometerMeasure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds | Device | – |
| skin incisionperformed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery. | Procedure or surgery | – |
Primary outcome
Relationship between pre-incision pupillary pain index and post-incision heart rate increase
Time frame: 4 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision blood pressure increase
Time frame: 4 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision bispectral index increase
Time frame: 4 minutes: one minute before incision, 3 minutes after incision
Relationship between pre-incision pupillary pain index and post-incision movement occurrence
Time frame: 4 minutes: one minute before incision, 3 minutes after incision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Isabelle Constant, MD-PHD study director
University Hospital Armand Trousseau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anesthesia, run by Pr Isabelle CONSTANT at 1 site in France.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 15 Mar 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between pre-incision pupillary pain index and post-incision heart rate increase (time frame: 4 minutes: one minute before incision, 3 minutes after incision). The study lists 4 primary outcomes in all. 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 15 Mar 2021.