Gender-specific Preoperative Anxiety Level and Postoperative Opioid Requirement After ENT Surgery.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
difficulty to understand study procedure, pain scoring system or questionnaires
surgical procedure warranting elective postoperative ventilation
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Anxiety level assessment
Other interventionTo 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: ENT surgical patients1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption
cumulative opioid consumption within PACU stay
Time frame
during the stay in the recovery room assessed up to 2 hoursSecondary outcomes
1
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
Time frame
during the stay in the recovery room assessed up to 2 hoursOther outcomes
1
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.
Time frame
on the 1 day before surgery and on the 1 day of surgery2
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
Time frame
during the stay in the recovery room assessed up to 2 hours3
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.
Time frame
on the 1 day before surgery and on the 1 day of surgery4
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.
Time frame
preoperative on the 1 day of surgery, immediately postoperative in the PACUSponsors and contacts
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Source ClinicalTrials.gov