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The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone group | Active Comparator | 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/ Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4 Mg/mL Injectable Solution | Drug | s. arm/group description |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominik Kaiser, MD | Contact | +41443865764 | dominik.kaiser@balgrist.ch | |
| Sabrina Catanzaro, study nurse | Contact | +41443867370 | sabrina.catanzaro@balgrist.ch |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Zingg, MD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Balgrist | Recruiting | Zurich | 8008 | Switzerland |
No If requested the individual participant data will be made available to other researchers.
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Only the investigators as well as the head of anasthesiology will be informed.
| NaCl 0.9% | Drug | s. arm/group description |
|
|
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 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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