Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.

Detailed Description
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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.

Official Title
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Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy- a Double-blinded Placebo Controlled RCT

Conditions
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Pain, Postoperative Nausea, Amount of Postoperative Opioid Use in Milligrams

Intervention / Treatment
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* Drug: Dexamethasone 4 Mg/mL Injectable Solution
* Drug: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone group<br>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. | Drug: Dexamethasone 4 Mg/mL Injectable Solution<br>* s. arm/group description<br>* Other names: Fortecortin Inject (Merck (Switzerland));|
| Placebo Comparator: Placebo/ Control group<br>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. | Drug: NaCl 0.9%<br>* s. arm/group description<br>* Other names: NaCL Braun (B Braun medical);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain level | The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain). | 6 hours postoperatively | 
| Postoperative pain level | The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain). | 24 hours postoperatively | 
| 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. | 48 hours postoperatively | 
| 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. | 48 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 hours postoperatively | 
| 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) | 24 hours postoperatively | 
| 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) | 48 hours postoperatively | 
| Number of vomiting events | The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea. | 48 hours postoperatively | 
| Physical therapy milestones 1 | First steps in the hallway | 1 week postoperatively | 
| Physical therapy milestones 2 | Walk up stairs | 1 week postoperatively | 
| Physical therapy milestones 3 | Bicycle ergometer can be used indipendently by the patient | 1 week postoperatively | 
| Length of hospitalization | The length of hospitalization will be obtained from the Patient Chart. | 2 weeks |