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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT05141591
Collaborator
(none)
300
1
19.6
15.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Anxiety level assessment

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 Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
ENT surgical patients

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [during the stay in the recovery room assessed up to 2 hours]

    cumulative opioid consumption within PACU stay

Secondary Outcome Measures

  1. 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

Other Outcome Measures

  1. Anxiety scores-APAIS [on the 1 day before surgery and on the 1 day of surgery]

    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.

  2. Postoperative Pain Score-VAS [during the stay in the recovery room assessed up to 2 hours]

    NRS score: evaluated at arrival and discharge from the PACU time to first analgesic (non-opioid, opioid) supplementation postoperatively in the PACU

  3. Anxiety scores-PCS [on the 1 day before surgery and on the 1 day of surgery]

    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.

  4. VAS-A. anxiety score [preoperative on the 1 day of surgery, immediately postoperative in the PACU]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marita Windpassinger M.D., Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05141591
Other Study ID Numbers:
  • 2006/2021
First Posted:
Dec 2, 2021
Last Update Posted:
Dec 2, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marita Windpassinger M.D., Principal Investigator, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2021