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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05141591
Enrollment
300
Registered
2021-12-02
Start date
2021-11-11
Completion date
2026-12-30
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Post Operative Pain, Anxiety

Keywords

catastrophizing, opioid consumption

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.

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.

Interventions

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumptionduring the stay in the recovery room assessed up to 2 hourscumulative opioid consumption within PACU stay

Secondary

MeasureTime frameDescription
Postoperative Pain Score-VAS-PACUduring the stay in the recovery room assessed up to 2 hoursmean 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

MeasureTime frameDescription
Anxiety scores-APAISon the 1 day before surgery and on the 1 day of surgeryAPAIS-Amsterdam Preoperative Anxiety and Information Scale Total range 6 to 30, a higher value reflects a higher anxiety as well as higher information requirement.
Postoperative Pain Score-VASduring the stay in the recovery room assessed up to 2 hoursNRS score: evaluated at arrival and discharge from the PACU time to first analgesic (non-opioid, opioid) supplementation postoperatively in the PACU
Anxiety scores-PCSon the 1 day before surgery and on the 1 day of surgeryPCS-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.
VAS-A. anxiety scorepreoperative on the 1 day of surgery, immediately postoperative in the PACUThe 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.

Countries

Austria

Contacts

Primary ContactMarita Windpassinger, MD
marita.windpassinger@meduniwien.ac.at+43 1 40400 41020
Backup ContactOlga Plattner, MD
olga.plattner@meduniwien.ac.at+43 1 40400 41020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026