Actively Recruiting
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy - a Double-blinded Placebo Controlled Randomized Trial
Led by Balgrist University Hospital · Updated on 2024-08-12
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of dexamethasone on reducing pain and nausea after periacetabular osteotomy, a surgical procedure with good long-term outcomes. Postoperative pain management is critical because high opioid use can cause side effects like nausea, which can hinder recovery. The study is a double-blinded randomized control trial involving up to 60 patients undergoing elective unilateral periacetabular osteotomy. Participants will be randomly assigned to receive either intravenous dexamethasone or a placebo. The dexamethasone group will get 12 mg of the drug before surgery and another 12 mg on the first postoperative morning. The control group will receive a saline solution instead of dexamethasone on the first postoperative morning. No additional preoperative drugs will be given. The trial compares pain levels, opioid consumption, nausea, and patient satisfaction between the two groups. During the study, researchers will measure pain levels at 6 and 24 hours after surgery, amount of opioid pain medication and anti-nausea drugs used within 48 hours, and patient satisfaction at multiple time points. They will also monitor vomiting events, physical therapy progress one week after surgery, and length of hospital stay up to two weeks. The study includes triple-blinded monitoring and aims to thoroughly assess the impact of dexamethasone on postoperative recovery.
CONDITIONS
Brief Title
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Undergoing general anesthesia
- Scheduled for elective periacetabular osteotomy for any reason
- Able to provide written informed consent
- Competent in German language
You will not qualify if you...
- Chronic pain patient or chronic lower back pain
- Use of steroid or immunosuppressive drugs within 6 months before surgery
- Renal failure or hepatic failure
- Relevant allergies
- Pregnancy or breastfeeding
- Contraindications for Fortecortin treatment according to Swissmedic
- Previous enrollment in this study
- Participation in another investigational drug study within 30 days before or during this study
- Known or suspected non-compliance, drug or alcohol abuse
- Illness as noted in warnings and precautions for dexamethasone and NaCl
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo elective unilateral periacetabular osteotomy surgery and receive perioperative intravenous dexamethasone or placebo to reduce postoperative pain and nausea.
1 surgery visit and approximately 6 post-operative visits
Duration - Up to 2 weeks
Participants are assessed for pain levels, opiate and anti-emetic consumption, patient satisfaction, physical therapy milestones, and length of hospitalization after surgery.
Assessments at 6, 24, and 48 hours postoperatively and 1 week postoperatively
Trial Site Locations
Total: 1 location
1
Uniklinik Balgrist
Zurich, Switzerland, 8008
Actively Recruiting
Research Team
D
Dominik Kaiser, MD
S
Sabrina Catanzaro, study nurse
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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