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

Recruiting

• Conditions: Anxiety; Acute Post Operative Pain
• Interventions: Other: Anxiety level assessment

• Registration Number: NCT05141591
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2021-11-10
• Study Start: 2021-11-11
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-12-29
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ENT surgical patients	Anxiety level assessment	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.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	during the stay in the recovery room assessed up to 2 hours	cumulative opioid consumption within PACU stay

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain Score-VAS-PACU	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

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria