Amount of Postoperative Opioid Use in Milligrams, Pain, Postoperative Nausea
Conditions
Brief summary
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
s. arm/group description
DRUGNaCl 0.9%
s. arm/group description
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Only the investigators as well as the head of anasthesiology will be informed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain level | 6 hours postoperatively | The VAS Pain score assesses pain Levels on a scale from 0 (no pain) to 10 (worst possible pain). |
| Amount of opiates (morphinequivalent) consumed | 48 hours postoperatively | The authors will assess the amount of Opiates the Patient needed due to the performed Surgery during the hospital stay. |
| Amount of anti-emetics consumed (Ondansetron) | 48 hours postoperatively | The authors will assess the amount of mg of anti- emetic drugs (Ondansetron) the Patient required during the Hospital stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical therapy milestones 2 | 1 week postoperatively | Walk up stairs |
| Patient satisfaction as assessed by the revised American pain society patient outcome questionnaire | 6 hours postoperatively | Patient satisfaction will be assessed by the revised American pain Society Patient Outcome questionnaire (APS-POQ-R). (0% worst, 100% best) |
| Length of hospitalization | 2 weeks | The length of hospitalization will be obtained from the Patient Chart. |
| Physical therapy milestones 3 | 1 week postoperatively | Bicycle ergometer can be used indipendently by the patient |
| Number of vomiting events | 48 hours postoperatively | The authors will count the number of vomiting events postoperatively as a direct marker for postoperative Nausea. |
| Physical therapy milestones 1 | 1 week postoperatively | First steps in the hallway |
Countries
Switzerland
Contacts
Primary ContactDominik Kaiser, MD
Backup ContactSabrina Catanzaro, study nurse
Outcome results
None listed