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NCT Number: NCT05141591

Gender-specific Preoperative Anxiety Level and 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.

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Key information

Conditions

Anxiety Acute Post Operative Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Vienna

Vienna, State of Vienna, 1090, Austria

Location status: Recruiting

Location contact

Marita Windpassinger, MD

CONTACT

[email protected]

+43140400 ext. 41020

Marita Windpassinger, MD

PRINCIPAL_INVESTIGATOR

Olga Plattner, MD

CONTACT

[email protected]

+43140400 ext. 41020

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Opioid consumption

    Time frame: during the stay in the recovery room assessed up to 2 hours

    cumulative opioid consumption within PACU stay

Secondary outcomes

  1. Postoperative Pain Score-VAS-PACU

    Time frame: during the stay in the recovery room assessed up to 2 hours

    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

Other outcomes

  1. Anxiety scores-APAIS

    Time frame: on the 1 day before surgery and on the 1 day of surgery

    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.

  2. Postoperative Pain Score-VAS

    Time frame: during the stay in the recovery room assessed up to 2 hours

    NRS score: evaluated at arrival and discharge from the PACU time to first analgesic (non-opioid, opioid) supplementation postoperatively in the PACU

  3. Anxiety scores-PCS

    Time frame: on the 1 day before surgery and on the 1 day of surgery

    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.

  4. VAS-A. anxiety score

    Time frame: preoperative on the 1 day of surgery, immediately postoperative in the PACU

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marita Windpassinger, MD

CONTACT

[email protected]

+43 1 40400 41020

Olga Plattner, MD

CONTACT

[email protected]

+43 1 40400 41020

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2021
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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