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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141591
• Other study ID #: 2006/2021
• Status: Recruiting
• Start date: November 11, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Medical University of Vienna
• Contact: Marita Windpassinger, MD
• Phone: +43 1 40400 41020
• Email: marita.windpassinger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2024
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain, Postoperative

Intervention

Other:
• Anxiety level assessment
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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety scores-APAIS	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.	on the 1 day before surgery and on the 1 day of surgery
Other	Postoperative Pain Score-VAS	NRS score: evaluated at arrival and discharge from the PACU time to first analgesic (non-opioid, opioid) supplementation postoperatively in the PACU	during the stay in the recovery room assessed up to 2 hours
Other	Anxiety scores-PCS	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.	on the 1 day before surgery and on the 1 day of surgery
Other	VAS-A. anxiety score	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.	preoperative on the 1 day of surgery, immediately postoperative in the PACU
Primary	Opioid consumption	cumulative opioid consumption within PACU stay	during the stay in the recovery room assessed up to 2 hours
Secondary	Postoperative Pain Score-VAS-PACU	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	during the stay in the recovery room assessed up to 2 hours