PPI-guided Postoperative Pain Therapy in the OR
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
PPI measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Pain focused on measuring Pupillary Pain Index, Postoperative Pain, Infrared Pupillometry, Postoperative Opioid Consumption
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- rapid sequence induction (RSI)
- psychiatric or mental disorders
- surgical procedure warranting elective postoperative ventilation
Sites / Locations
- Medical University Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PPI-guided pain therapy
Non-PPI-guided pain therapy
Arm Description
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.
The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant.
Outcomes
Primary Outcome Measures
Opioid Consumption
cumulative opioid consumption within first 2 postoperative hours
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04176289
First Posted
November 22, 2019
Last Updated
April 21, 2021
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04176289
Brief Title
PPI-guided Postoperative Pain Therapy in the OR
Official Title
PPI-guided Postoperative Pain Therapy in the OR
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pupillary Pain Index, Postoperative Pain, Infrared Pupillometry, Postoperative Opioid Consumption
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blinded study design (participants, evaluator)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPI-guided pain therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-PPI-guided pain therapy
Arm Type
No Intervention
Arm Description
The amount of administered piritramid in the OR will be left to the discretion of the anesthesiologist attending the participant.
Intervention Type
Diagnostic Test
Intervention Name(s)
PPI measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
cumulative opioid consumption within first 2 postoperative hours
Time Frame
first 2 postoperative hours
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
first 2 postoperative hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
rapid sequence induction (RSI)
psychiatric or mental disorders
surgical procedure warranting elective postoperative ventilation
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
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PPI-guided Postoperative Pain Therapy in the OR
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