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PPI-guided Postoperative Pain Therapy in the OR

NCT04176289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-04-23

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

PPI measurement

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2021-03-10
Completion
2021-03-10

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176289 on ClinicalTrials.gov