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The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after hip arthroscopy.
Hip arthroscopy (HAS) 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 in 250ml saline solution) to a control group (placebo) (1x 250ml 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 60 patients receiving elective unilateral HAS 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. 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 4mg | 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 (wost possible pain). | 6 hours postoperatively |
| Postoperative pain level | The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (wost possible pain). | 24 hours postoperatively |
| Amount of opiates (morphinequivalent) consumed | We 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) | We will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay. | 48 houts 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). | 6 hours postoperatively |
| Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire |
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Inclusion Criteria:
• Age ≥ 18 years
Exclusion Criteria:
• Chronic pain patient, chronic lower back pain
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Zingg, MD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Balgrist | Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38456291 | Derived | Kaiser D, Hoch A, Dimitriou D, Groeber T, Bomberg H, Aguirre JA, Eichenberger U, Zingg PO. Perioperative Intravenous Dexamethasone Significantly Reduces Postoperative Opioid Requirement and Nausea After Unilateral Elective Hip Arthroscopy: A Randomized Double-blinded Placebo-controlled Trial. Am J Sports Med. 2024 Apr;52(5):1165-1172. doi: 10.1177/03635465241232157. Epub 2024 Mar 8. |
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If requested the individual participant data will be made available to other researchers.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 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). |
| 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). | 48 hours postoperatively |
| Number of vomiting events | We will Count the number of vomiting Events postoperatively as a direct marker for postoperative Nausea. | 48 hours postoperatively |
| Physical therapy milestones | Our patients will be instructed and perform different postoperative Rehabilitation steps including (first steps in the hallway, Walking up and down stairs, bicycle Ergometer) | 48 hours postoperatively |
| Length of hospitalization | The length of hospitalization will be obtained from the Patient Chart. | after 1 week |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |