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

NCT05141591 | Recruiting

• 1 other identifier: 2006/2021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Acute Post Operative Pain

Keywords

catastrophizing; opioid consumption

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  cumulative opioid consumption within PACU stay

  during the stay in the recovery room assessed up to 2 hours

Secondary Outcomes (1)

• Postoperative Pain Score-VAS-PACU

  during the stay in the recovery room assessed up to 2 hours

Other Outcomes (4)

• Anxiety scores-APAIS

  on the 1 day before surgery and on the 1 day of surgery

• Postoperative Pain Score-VAS

  during the stay in the recovery room assessed up to 2 hours

• Anxiety scores-PCS

  on the 1 day before surgery and on the 1 day of surgery

Study Arms (1)

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

Interventions

Anxiety level assessment OTHER

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.

ENT surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marita Windpassinger, MD

CONTACT

+43 1 40400 41020; marita.windpassinger@meduniwien.ac.at

Olga Plattner, MD

CONTACT

+43 1 40400 41020; olga.plattner@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 2, 2021
• Study Start: November 11, 2021
• Primary Completion (Estimated): December 29, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

AU (1)