PPI-guided Postoperative Pain Therapy in the OR

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Diagnostic Test: PPI measurement

• Registration Number: NCT04176289
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Study Start: 2020-03-10
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPI-guided pain therapy	PPI measurement	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.

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	first 2 postoperative hours	cumulative opioid consumption within first 2 postoperative hours

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain	first 2 postoperative hours	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.

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria