PPI-guided Postoperative Pain Therapy in the OR

NCT04176289 | Completed

• 1 other identifier: 2112/2019
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Pupillary Pain Index; Postoperative Pain; Infrared Pupillometry; Postoperative Opioid Consumption

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  cumulative opioid consumption within first 2 postoperative hours

  first 2 postoperative hours

Secondary Outcomes (1)

• Postoperative Pain

  first 2 postoperative hours

Study Arms (2)

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.

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.

Interventions

PPI measurement DIAGNOSTIC_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.

PPI-guided pain therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded study design (participants, evaluator)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 25, 2019
• Study Start: March 10, 2020
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

AU (1)