Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBalgrist University Hospital
About this trial
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
General anasthesia
Elective periacetabular osteotomy for any reason
Written informed consent as documented by signature (Appendix Informed Consent Form)
Disqualifiers
Chronic pain patient, chronic lower back pain
Steroid or immunosuppressive drugs used within 6 months of surgery
Renal failure, hepatic failure
Relevant allergies
Trial design
Design model
Parallel
Treatments tested in this trial
Dexamethasone 4 Mg/mL Injectable Solution
Drugs. arm/group description
NaCl 0.9%
Drugs. arm/group description
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Dexamethasone groupActive comparator 1 intervention
Group B: Placebo/ Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative pain level
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain).
Time frame
6 hours postoperatively2
Postoperative pain level
The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain).
Time frame
24 hours postoperatively3
Amount of opiates (morphinequivalent) consumed
The authors will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay.
Time frame
48 hours postoperatively4
Amount of anti-emetics consumed (Ondansetron)
The authors will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay.
Time frame
48 hours postoperativelySecondary outcomes
1
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R). (0% worst, 100% best)
Time frame
6 hours postoperatively2
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).(0% worst, 100% best)
Time frame
24 hours postoperatively3
Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire
Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R).(0% worst, 100% best)
Time frame
48 hours postoperatively4
Number of vomiting events
The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea.
Time frame
48 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov