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

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Medical University of Vienna

Status

Enrolling

Conditions

Acute Post Operative Pain
Anxiety

Treatments

Other: Anxiety level assessment

Study type

Observational

Funder types

Other

Identifiers

NCT05141591
2006/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

ENT surgical patients
Description:
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.
Treatment:
Other: Anxiety level assessment

Trial contacts and locations

1

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Central trial contact

Olga Plattner, MD; Marita Windpassinger, MD

Data sourced from clinicaltrials.gov

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