Postoperative PainNCT02058511
Infrared Pupillometry During General Anesthesia to Predict Pain
A study testing Anesthesia Premedication, Induction and Maintenance and Pupillometry after administration of anesthetic drugs in people with Postoperative Pain and Objective Assessment of Sedation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The study comprises of a series of pupillary measurements using infrared pupillometry in patients undergoing arthroscopic knee surgery of any type. Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Pain, Objective Assessment of Sedation
- What is being tested?
- Anesthesia Premedication, Induction and Maintenance and Pupillometry after administration of anesthetic drugs
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years undergoing arthroscopic knee surgery of any type
Who cannot join
- Blindness
- Anisocoria
- History of opioid abuse
- Chronic pain patients
- Gastric Reflux Disease (due to the use of laryngeal masks in the study)
- Non english speaking patients
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Institute
San Francisco, California, 94158
About this study
Official title: Intraoperative Use of Infrared Pupillometry During General Anesthesia to Predict Pain and Quality of Regional Anesthesia After Surgery
The study comprises of a series of pupillary measurements using infrared pupillometry in patients undergoing arthroscopic knee surgery of any type.
Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. This may help to predict the amount of discomfort a patient will be experiencing after emergence from general anesthesia.
Read more
In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after indiction of anesthesia, as well as during recovery. These spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed.
The aim of the study is
- to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks will block the PRD. This would allow assessment of block success in the anesthetized patient.
- to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.
Read the detailed description
The planned study is a prospective cohort study.
Patients undergoing arthroscopic knee surgery of any type (debridements, repair of anterior (ACL) or posterior cruciform ligaments (PCL), meniscectomies, medial (MCL) or lateral collateral ligament (LCL) repair, as well as microfracture surgery will be enrolled.
During anesthesia, infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. The PRD is measurable under general anesthesia in spite of the fact that the patient does not "feel" or experience the painful stimulus.
The aim of the study is
- to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks (performed before the start of anesthesia) will block the PRD evoked by a painful stimulus such electrical stimulation before procedure start. This would allow assessment of block success in the anesthetized patient.
- to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.
Knee arthroscopies are routinely performed under general anesthesia with or without regional anesthesia, depending on the anticipated extent of surgery and the preferences of the anesthesiologist and surgeon. The assessment of the PRD and/or hipppus before emergence would identify those patients who would benefit from an additional nerve block before emergence to achieve better pain control immediately postoperatively and to reduce the demand for postoperative analgesics.
The planned investigation tries to achieve two novel findings. First, the measurement of the PRD at the start of surgery will demonstrate whether a nerve block successfully blocks the initial surgical stimulus. There is currently no method available that can assess block success in the anesthetized patient. Secondly, the measurement at the end of the surgery tries to predict the amount of pain following emergence from surgery. Pain may be experienced by patients without nerve blocks as well as with nerve blocks, as the latter may have failed or incomplete blocks, or may had a more extensive procedure that cannot be completely covered by the block administered preoperatively. Identifying these patients may allow treatment to minimize discomfort following emergence.
Pupillary reflex dilation describes the dilation of the pupil following a painful stimulus. The dilation last several seconds. Pupillometry using an infrared pupillometer allows the quantification of the reflex dilation. The PRD can be given a numerical value that reflects the extent of the dilation. A recently published study demonstrated the correlation of the extend of the PRD with pain scores and opioid requirements postoperatively. However, this study was done in awake patients following surgery. The aim of this study is to predict analgesia requirements in patients still under general anesthesia, before they experience postoperative pain. We expect that infrared pupillometry during general anesthesia can predict pain following surgery. Once this has been established, this knowledge and its application would allow the anesthesiologist to initiate pain-relieving interventions such as additional nerve blocks or administration of analgesics before emergence of the patients from general anesthesia.
In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after induction of anesthesia, as well as during recovery. These spontaneously occurring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed.
- Being tested
- Anesthesia Premedication, Induction and Maintenance, Pupillometry after administration of anesthetic drugs
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia Premedication, Induction and MaintenanceDrug
The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants.
The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain.
Pupillometry after administration of anesthetic drugsProcedure or surgery
All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded.
Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period
The administered drugs are:
Midazolam 1-2 mg iv, Fentanyl 1mcg/kg body weight, Propofol for anesthesia induction 2-2.5 mg/kg body weight, Sevoflurane as needed for maintenance of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | all enrolled patients undergo the same protocol/ treatment:
Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs Receives: Drug: Anesthesia Premedication, Induction and Maintenance; Procedure: Pupillometry after administration of anesthetic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain in Recovery Room
Pain as assessed by visual analogue score at arrival of the patient in the recovery room Scale goes from 0-10, with 10 indicating the worst pain possible
Measured: at arrival in recovery room
Secondary outcomes (1)
Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions
Pupillary Reflex Dilation is measured intraoperatively at incision and at the end of the case as a possible indicator of success of regional anesthesia.
Measurement of this requires stable experimental conditions, most notably sufficient depth of anesthesia.
Measured: measurements were taken at two time points during surgery. Each measurement took 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Preliminary results showed no ability to predict pain by measuring hippus with pupillometry
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Behrends, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058511
- Sponsor's protocol ID
- Pupillometry and Analgesia
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2014
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Infrared Pupillometry During General Anesthesia to Predict Pain and Quality of Regional Anesthesia After Surgery
- ClinicalTrials.gov ID
- NCT02058511
- Acronym / sponsor ID
- Pupillometry and Analgesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary results showed no ability to predict pain by measuring hippus with pupillometry
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Feb 2014 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study comprises of a series of pupillary measurements using infrared pupillometry in patients undergoing arthroscopic knee surgery of any type.
Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. This may help to predict the amount of discomfort a patient will be experiencing after emergence from general anesthesia.
In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after indiction of anesthesia, as well as during recovery. These spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed.
The aim of the study is
- to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks will block the PRD. This would allow assessment of block success in the anesthetized patient.
- to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.
Detailed description
The planned study is a prospective cohort study.
Patients undergoing arthroscopic knee surgery of any type (debridements, repair of anterior (ACL) or posterior cruciform ligaments (PCL), meniscectomies, medial (MCL) or lateral collateral ligament (LCL) repair, as well as microfracture surgery will be enrolled.
During anesthesia, infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. The PRD is measurable under general anesthesia in spite of the fact that the patient does not "feel" or experience the painful stimulus.
The aim of the study is
- to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks (performed before the start of anesthesia) will block the PRD evoked by a painful stimulus such electrical stimulation before procedure start. This would allow assessment of block success in the anesthetized patient.
- to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.
Knee arthroscopies are routinely performed under general anesthesia with or without regional anesthesia, depending on the anticipated extent of surgery and the preferences of the anesthesiologist and surgeon. The assessment of the PRD and/or hipppus before emergence would identify those patients who would benefit from an additional nerve block before emergence to achieve better pain control immediately postoperatively and to reduce the demand for postoperative analgesics.
The planned investigation tries to achieve two novel findings. First, the measurement of the PRD at the start of surgery will demonstrate whether a nerve block successfully blocks the initial surgical stimulus. There is currently no method available that can assess block success in the anesthetized patient. Secondly, the measurement at the end of the surgery tries to predict the amount of pain following emergence from surgery. Pain may be experienced by patients without nerve blocks as well as with nerve blocks, as the latter may have failed or incomplete blocks, or may had a more extensive procedure that cannot be completely covered by the block administered preoperatively. Identifying these patients may allow treatment to minimize discomfort following emergence.
Pupillary reflex dilation describes the dilation of the pupil following a painful stimulus. The dilation last several seconds. Pupillometry using an infrared pupillometer allows the quantification of the reflex dilation. The PRD can be given a numerical value that reflects the extent of the dilation. A recently published study demonstrated the correlation of the extend of the PRD with pain scores and opioid requirements postoperatively. However, this study was done in awake patients following surgery. The aim of this study is to predict analgesia requirements in patients still under general anesthesia, before they experience postoperative pain. We expect that infrared pupillometry during general anesthesia can predict pain following surgery. Once this has been established, this knowledge and its application would allow the anesthesiologist to initiate pain-relieving interventions such as additional nerve blocks or administration of analgesics before emergence of the patients from general anesthesia.
In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after induction of anesthesia, as well as during recovery. These spontaneously occurring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Anesthesia Premedication, Induction and Maintenance, Procedure: Pupillometry after administration of anesthetic drugsall enrolled patients undergo the same protocol/ treatment: Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years undergoing arthroscopic knee surgery of any type
Key exclusion criteria (7 listed)
- Blindness
- Anisocoria
- History of opioid abuse
- Chronic pain patients
- Gastric Reflux Disease (due to the use of laryngeal masks in the study)
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 |
|---|---|---|
| Anesthesia Premedication, Induction and MaintenanceThe enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants. The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain. | Drug | Intervention Group |
| Pupillometry after administration of anesthetic drugsAll study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded. Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period The administered drugs are: Midazolam 1-2 mg iv, Fentanyl 1mcg/kg body weight, Propofol for anesthesia induction 2-2.5 mg/kg body weight, Sevoflurane as needed for maintenance of general anesthesia. | Procedure or surgery | Intervention Group |
Primary outcome
Pain in Recovery Room
Time frame: at arrival in recovery room
Pain as assessed by visual analogue score at arrival of the patient in the recovery room Scale goes from 0-10, with 10 indicating the worst pain possible
1 secondary outcome
Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions
Time frame: measurements were taken at two time points during surgery. Each measurement took 30 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Anesthesia Premedication, Induction and Maintenance and Pupillometry after administration of anesthetic drugs in people with Postoperative Pain and Objective Assessment of Sedation, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 15 Feb 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain in Recovery Room (time frame: at arrival in recovery room). 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 Feb 2019.