Gender-specific Preoperative Anxiety Level and Postoperative Opioid Requirement After ENT Surgery.

The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.

The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.

The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Acute Post Operative Pain
• Intervention / Treatment: Other: Anxiety level assessment

Detailed Description

Background Due to the frequency of surgeries, acute postsurgical pain (APSP) is a common clinical problem. In this study, the investigators will investigate pre-surgical psychological factors associated with the experience of APSP in ENT surgery.

The study will be designed to investigate the impact of gender-specific preoperative anxiety states, using the STOA, APAIS, PCS and VAS-A scoring systems, on postoperative opioid consumption after elective ENT surgery.

These findings may have important implications for developing more personalized strategies in acute postoperative pain therapy in selected patients.

Aim Study aim is to investigate the impact of the preoperative anxiety level, using the validated STOA questionnaire, on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.

The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.

The investigators hypothesize that a higher preoperative anxiety state, is a predictive factor of opioid requirement in the early postoperative period after ENT surgery.

Methods Surgery-related psychological factors like anxiety state will be assessed gender-specific, in patients scheduled for elective ENT surgery by validated questionnaires (STOA, APAIS, PCS and VAS-A), filled out by the patient the day before surgery and on the day of surgery, to investigate the correlation with the postoperative opioid consumption.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Marita Windpassinger, MD; Phone Number: +43 1 40400 41020; Email: marita.windpassinger@meduniwien.ac.at
• Study Contact Backup: Name: Olga Plattner, MD; Phone Number: +43 1 40400 41020; Email: olga.plattner@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna
    • Contact: Marita Windpassinger, MD; Phone Number: 41020 +43140400; Email: marita.windpassinger@meduniwien.ac.at
    • Contact: Olga Plattner, MD; Phone Number: 41020 +43140400; Email: olga.plattner@meduniwien.ac.at
    • Principal Investigator: Marita Windpassinger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The investigators will study ASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. Written informed consent will be obtained from each participant.

Description

Inclusion Criteria:

• American Society of Anesthesiology (ASA) physical status I-IV
• able to read and understand the information sheet and to sign the consent form
• being scheduled for elective ENT surgery under general anesthesia
• written informed consent
• age≥18 years

Exclusion Criteria:

• difficulty to understand study procedure, pain scoring system or questionnaires
• surgical procedure warranting elective postoperative ventilation

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

ENT surgical patients; ASA physical status I-IV adult subjects, ≥ 18 years of age, scheduled for elective ENT surgeries in the Department of ENT at the Medical University of Vienna. On the day before elective ENT- surgery patients will be asked to complete self-administered questionnaires (STOA, APAIS, PCS) concerning their emotional and anxiety state. These questionnaires will be re-tested on the day of surgery and opioid consumption during the stay in the recovery room documented.

Other: Anxiety level assessment; To investigate the impact of psychological variables e.g. pre-surgical anxiety on postoperative opioid consumption and pain level, the investigators will perform the STOA, APAIS, PCS and the VAS-A anxiety questionnaires before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	cumulative opioid consumption within PACU stay	during the stay in the recovery room assessed up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Score-VAS-PACU	mean pain level on an 11-point verbal Likert response score recorded at 30-minute intervals during the PACU stay, ranging between 0 and 10, with higher levels indicating higher pain intensity	during the stay in the recovery room assessed up to 2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety scores-APAIS	APAIS-Amsterdam Preoperative Anxiety and Information Scale Total range 6 to 30, a higher value reflects a higher anxiety as well as higher information requirement.	on the 1 day before surgery and on the 1 day of surgery
Postoperative Pain Score-VAS	NRS score: evaluated at arrival and discharge from the PACU time to first analgesic (non-opioid, opioid) supplementation postoperatively in the PACU	during the stay in the recovery room assessed up to 2 hours
Anxiety scores-PCS	PCS-Pain catastrophizing scale The higher the total score, the greater the individual risk of catastrophic pain. The PCS score ranges from 0 to 52 points.	on the 1 day before surgery and on the 1 day of surgery
VAS-A. anxiety score	The VAS-A scale is comprised of a horizontal line 100mm long with the indication "no anxiety" to the left and "worst possible anxiety" to the right. The higher the total score, the greater the individual anxiety level.	preoperative on the 1 day of surgery, immediately postoperative in the PACU

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: opioid consumption; catastrophizing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: 2006/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No