Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy
NCT ID: NCT05120076
Last Updated: 2024-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2021-07-16
2024-08-31
Brief Summary
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Detailed Description
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Promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement.
It is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg Amp. Fortecortin =12mg prior to surgery and 3x4mg Amp. Fortecortin = 12mg at 8.00am of the first postoperative day) to a control group (placebo) (3ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction.
A double-blinded prospective randomized control trial including up to 60 patients receiving elective unilateral PAO will be conducted.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Dexamethasone 4 Mg/mL Injectable Solution
s. arm/group description
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.
NaCl 0.9%
s. arm/group description
Interventions
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Dexamethasone 4 Mg/mL Injectable Solution
s. arm/group description
NaCl 0.9%
s. arm/group description
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* General anasthesia
* Elective periacetabular osteotomy for any reason
* Written informed consent as documented by signature (Appendix Informed Consent Form)
* Competent German language skills
Exclusion Criteria
* Steroid or immunosuppressive drugs used within 6 months of surgery
* Renal failure, hepatic failure
* Relevant allergies
* Pregnancy/ Breast feeding
* Contraindications for Fortecortin treatment according to Swissmedic
* Previous enrollment into the current study
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Known or suspected non-compliance, drug or alcohol abuse Illness according to "Warnings and Precautions of Dexamethasone and NaCl"
18 Years
99 Years
ALL
Yes
Sponsors
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Balgrist University Hospital
OTHER
Responsible Party
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Principal Investigators
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Patrick Zingg, MD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Locations
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Uniklinik Balgrist
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DEXA and PAO
Identifier Type: -
Identifier Source: org_study_id
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