Postoperative PainNCT04176289
PPI-guided Postoperative Pain Therapy in the OR
A study testing PPI measurement in people with Postoperative Pain, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- PPI measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustria
- Study dates
- 10 Mar 2020to 10 Mar 2021
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) physical status I-II
- able to read and understand the information sheet and to sign the consent form
- being scheduled for elective ENT surgery under general anesthesia
- age≥18 years
Who cannot join
- ASA physical status of III and above
- previous history of either drug or alcohol abuse
- difficulty to understand pain scoring system
- chronic users of analgesics or had used opioids within 12 h before surgery
- implanted electronic medical devices
- ophthalmologic diseases
Show all 9Show fewer
- rapid sequence induction (RSI)
- psychiatric or mental disorders
- surgical procedure warranting elective postoperative ventilation
Trial locations and contacts
1 site in 1 country.
About this study
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.
Read the detailed description
Abstract
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery. Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.
Background
The evaluation of pain intensity during the immediate postoperative period in the operating room (OR) is a key factor for post interventional pain treatment. However, this evaluation may be difficult when patients are still intubated, restricted in consciousness or are showing verbal impairment due to ENT surgery. Verbally impaired patients are at increased risk of under treatment for pain.
With rising opioid consumption, the risk of postoperative side effects like nausea and vomiting, sedation with a longer recovery time or respiratory depression increases. Especially in the cohort of ENT surgery patients, where a difficult airway is regularly presented, such side effects should be avoided. A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable.
The pupillary dilatation reflex (PDR), measured by pupillometry, has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale (NRS).
Aims
Primary aim of this study is to investigate if a PPI-guided opioid administration immediately postoperative in the OR leads to less opioid requirement during the first 2 postoperative hours compared to a non-PPI guided treatment.
Secondary aim is to evaluate postoperative pain during the first 2 postoperative hours in patients after PPI-guided versus non-PPI guided opioid therapy in the OR.
Hypotheses
The investigators hypothesis that through a targeted pain therapy based on the measurement of immediate postoperative PPI score, opioid consumption and pain intensity can be reduced during the first 2 postoperative hours.
Methods
The study will be done by observing postoperative pain intensity using pupillometry in patients scheduled for elective ENT surgery, carrying out pain intervention (opioid therapy) and re-observing to verify the effectiveness of the targeted postoperative opioid administration in the OR. Pain on an 11-point verbal Likert response score and total opioid consumption will be recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours.
- Conditions
- Postoperative Pain
- Being tested
- PPI measurement
- Keywords
- Pupillary Pain Index, Postoperative Pain, Infrared Pupillometry, Postoperative Opioid 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.
PPI measurementDiagnostic test
The pupillary dilatation reflex (PDR), induced by a standardized noxious stimulus will be measured as Pupillary Pain Index(PPI,11-point numeric scale, 0= no pain, 10= worst pain) determined with a portable pupillometer. Patients experiencing mild or more severe pain (PPI> 3) will receive intravenous opioid titration (piritramid, 3 mg bolus steps) and PPI measurement performed before and after intravenous opioid titration.
| Study group | Role | What they receive |
|---|---|---|
| PPI-guided pain therapy | Active comparator | At the end of anesthesia a PPI targeted opioid pain therapy will be performed by gradual administration of piritramid in 3 mg steps up to a PPI score ≤ 3. Receives: Diagnostic Test: PPI measurement |
| Non-PPI-guided pain therapy | No intervention | The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
cumulative opioid consumption within first 2 postoperative hours
Measured: first 2 postoperative hours
Secondary outcomes (1)
Postoperative Pain
Pain on an 11-point verbal Likert response score (VAS score) recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours. The 11-point numeric scale ranges between 0, meaning no pain, and 10, meaning worst pain.
Measured: first 2 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start10 Mar 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
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 Medical University of ViennaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Windpassinger M.D., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176289
- Sponsor's protocol ID
- 2112/2019
- Status last verified
- Apr 2021
- First submitted
- 22 Nov 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPI-guided Postoperative Pain Therapy in the OR
- ClinicalTrials.gov ID
- NCT04176289
- Acronym / sponsor ID
- 2112/2019
- Conditions
- Postoperative Pain
- Keywords
- Pupillary Pain Index, Postoperative Pain, Infrared Pupillometry, Postoperative Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 25 Nov 2019 (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.
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery.
Detailed description
Abstract
The study will be designed to investigate the effect of pupillary pain index (PPI)-guided compared to non-PPI-guided postoperative pain therapy, conducted immediately at the end of surgery, on total postoperative opioid consumption during the first 2 postoperative hours after elective ENT surgery. Pupillometric pain measurements helps clinicians determine and administer the optimized amount of opioids and so avoids opioid-induced side effects.
Background
The evaluation of pain intensity during the immediate postoperative period in the operating room (OR) is a key factor for post interventional pain treatment. However, this evaluation may be difficult when patients are still intubated, restricted in consciousness or are showing verbal impairment due to ENT surgery. Verbally impaired patients are at increased risk of under treatment for pain.
With rising opioid consumption, the risk of postoperative side effects like nausea and vomiting, sedation with a longer recovery time or respiratory depression increases. Especially in the cohort of ENT surgery patients, where a difficult airway is regularly presented, such side effects should be avoided. A means of predicting immediate postoperative pain after surgery and the response to opiate analgesics would therefore be highly desirable.
The pupillary dilatation reflex (PDR), measured by pupillometry, has been successfully used to assess intraoperative analgesic component of anesthetic regimes and correlates with pain intensity measured on a numeric rating scale (NRS).
Aims
Primary aim of this study is to investigate if a PPI-guided opioid administration immediately postoperative in the OR leads to less opioid requirement during the first 2 postoperative hours compared to a non-PPI guided treatment.
Secondary aim is to evaluate postoperative pain during the first 2 postoperative hours in patients after PPI-guided versus non-PPI guided opioid therapy in the OR.
Hypotheses
The investigators hypothesis that through a targeted pain therapy based on the measurement of immediate postoperative PPI score, opioid consumption and pain intensity can be reduced during the first 2 postoperative hours.
Methods
The study will be done by observing postoperative pain intensity using pupillometry in patients scheduled for elective ENT surgery, carrying out pain intervention (opioid therapy) and re-observing to verify the effectiveness of the targeted postoperative opioid administration in the OR. Pain on an 11-point verbal Likert response score and total opioid consumption will be recorded by a blinded investigator at 30-minute intervals for the initial 2 postoperative hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI-guided pain therapy | Active comparator | Diagnostic Test: PPI measurementAt the end of anesthesia a PPI targeted opioid pain therapy will be performed by gradual administration of piritramid in 3 mg steps up to a PPI score ≤ 3. |
| Non-PPI-guided pain therapy | No intervention | –The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology (ASA) physical status I-II
- able to read and understand the information sheet and to sign the consent form
- being scheduled for elective ENT surgery under general anesthesia
- age≥18 years
Key exclusion criteria (9 listed)
- ASA physical status of III and above
- previous history of either drug or alcohol abuse
- difficulty to understand pain scoring system
- chronic users of analgesics or had used opioids within 12 h before surgery
- implanted electronic medical devices
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 |
|---|---|---|
| PPI measurementThe pupillary dilatation reflex (PDR), induced by a standardized noxious stimulus will be measured as Pupillary Pain Index(PPI,11-point numeric scale, 0= no pain, 10= worst pain) determined with a portable pupillometer. Patients experiencing mild or more severe pain (PPI> 3) will receive intravenous opioid titration (piritramid, 3 mg bolus steps) and PPI measurement performed before and after intravenous opioid titration. | Diagnostic test | PPI-guided pain therapy |
Primary outcome
Opioid Consumption
Time frame: first 2 postoperative hours
cumulative opioid consumption within first 2 postoperative hours
1 secondary outcome
Postoperative Pain
Time frame: first 2 postoperative hours
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 23 Apr 2021.
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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 PPI measurement in people with Postoperative Pain, run by Medical University of Vienna at 1 site in Austria.
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 9 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 23 Apr 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 Austria. 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?
Opioid Consumption (time frame: first 2 postoperative hours). 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 23 Apr 2021.