Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:
• Age ≥ 18 years
• General anasthesia
• Elective periacetabular osteotomy for any reason
• Written informed consent as documented by signature (Appendix Informed Consent Form)
• Competent German language skills
Locations
Other Locations
Switzerland
Uniklinik Balgrist
RECRUITING
Zurich
Contact Information
Primary
Dominik Kaiser, MD
dominik.kaiser@balgrist.ch
+41443865764
Backup
Sabrina Catanzaro, study nurse
sabrina.catanzaro@balgrist.ch
+41443867370
Time Frame
Start Date: 2021-07-16
Estimated Completion Date: 2024-08-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Dexamethasone group
The patients in the dexamethasone group will receive 12mg dexamethasone (Fortecortin ®) intravenously 15-60 minutes prior to surgery while in general anasthesia as well as 12mg dexamethasone intravenously (Fortecortin®) on the first postoperative day at approx. 8.00a.m. by the investigators.
Placebo_comparator: Placebo/ Control group
The patients will not receive any additional drugs preoperatively. 3ml of a 0.9% NaCl Solution (NaCl B. Braun Inf Lös 0.9 % 250ml Ecoflac plus®) will be administered at approx. 8.00 a.m. on the first postoperative day by the investigators.
Related Therapeutic Areas
Sponsors
Leads: Balgrist University Hospital