Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone 4 Mg/mL Injectable Solution, NaCl 0.9%.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative Nausea, Amount of Postoperative Opioid Use in Milligrams. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT
Overview
The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.
Detailed description
Bernese periacetabular osteotomy (PAO) is a standard procedure with good mid and long-term results. Postoperative pain is a great concern and postoperative pain management of great importance. High demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation.
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.
Interventions
- Drug Dexamethasone 4 Mg/mL Injectable Solution
s. arm/group description - Drug NaCl 0.9%
s. arm/group description
Primary outcome measures
- Postoperative pain level [Time frame: 6 hours postoperatively]
- Postoperative pain level [Time frame: 24 hours postoperatively]
- Amount of opiates (morphinequivalent) consumed [Time frame: 48 hours postoperatively]
- Amount of anti-emetics consumed (Ondansetron) [Time frame: 48 hours postoperatively]
Secondary outcome measures (8)
- Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire [Time frame: 6 hours postoperatively]
- Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire [Time frame: 24 hours postoperatively]
- Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire [Time frame: 48 hours postoperatively]
- Number of vomiting events [Time frame: 48 hours postoperatively]
- Physical therapy milestones 1 [Time frame: 1 week postoperatively]
- Physical therapy milestones 2 [Time frame: 1 week postoperatively]
- Physical therapy milestones 3 [Time frame: 1 week postoperatively]
- Length of hospitalization [Time frame: 2 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Chronic pain patient, chronic lower back pain
- 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"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Uniklinik Balgrist — Zurich
Identifiers
NCT: NCT05120076 · DEXA and PAO