Clinical trial NCT05141591: Gender-specific Preoperative Anxiety Level and Postoperative Opioid Requirement After ENT Surgery.
Official title: The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anxiety
Acute Post Operative Pain
Keywords: catastrophizing
opioid consumption
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption
timeFrame: during the stay in the recovery room assessed up to 2 hours
Secondary outcomes:
measure: Postoperative Pain Score-VAS-PACU
timeFrame: during the stay in the recovery room assessed up to 2 hours
Other outcomes:
measure: Anxiety scores-APAIS
timeFrame: on the 1 day before surgery and on the 1 day of surgery
measure: Postoperative Pain Score-VAS
timeFrame: during the stay in the recovery room assessed up to 2 hours
measure: Anxiety scores-PCS
timeFrame: on the 1 day before surgery and on the 1 day of surgery
measure: VAS-A. anxiety score
timeFrame: preoperative on the 1 day of surgery, immediately postoperative in the PACU
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References: