Hip DysplasiaPhase 4DEX-GANZNCT03161938
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase
A Phase 4 study testing Dexamethasone in people with Hip Dysplasia and Postoperative Complications, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Dysplasia, Postoperative Complications
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2017to 20 Aug 2019
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned unilateral periacetabular osteotomy
- informed signed consent
Who cannot join
- Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)
- ongoing (<30 days) use of immunosuppressive therapy
- insulin dependent diabetes
- pregnancy/breastfeeding
- allergies toward study medication, or medication in the standard treatment
- surgery cannot be performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Periacetabular (GANZ) Osteotomy
The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after periacetabular osteotomy. Primary outcome is the proportion of patients who have moderate to severe postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific complications in the post anaesthesia phase, pain and nausea the first 5 days, wound infection and readmissions the first 30 days after surgery.
The investigators hypothesize that the frequency of moderate to severe pain and organspecific complications in the post anaesthesia care unit will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections or readmissions.
Read the detailed description
Post-surgery, patients are traditionally observed and treated in post-anesthesia care units (PACU) until they are discharged to the ward (or directly home) assessed by standardized international discharge criteria.
The research project "Why in PACU?" (Rigshospitalet, Denmark), has since the beginning of 2016 systematically collected and analyzed procedure-related complications in the recovery phase. The complications include pain, nausea/vomiting, circulatory and respiratory problems, orthostatic intolerance and cognitive disorders. Common to all the above-mentioned post-operative problems are the possible links to the inflammatory response caused by the surgical trauma.
Glucocorticoids can in this context be central for the reduction of acute postoperative organ dysfunctions, caused by the anti-inflammatory effect. In a number of different surgical procedures, single dose, pre-operative glucocorticoids have been shown to reduce post-operative nausea and vomiting (PONV), acute pain and need of opioids as well as accelerate the convalescence.
Meta-analyses also showed that single-dose administration of glucocorticoids (methylprednisolone and dexamethasone) for surgical patients is safe as opposed to long-term treatment.
The "Why in PACU?" database shows that 70 % of patients experience moderate to severe pain in the immediate postoperative phase. This is despite a multimodal analgesic regime with preoperative analgesics and local analgesic catheter in the surgical site.
Opioids are frequently administered to relieve pain, resulting in sedation, risk of hypoxia and delaying mobilization.
Patients having Ganz osteotomy are primarily young women with hipdysplasia, that are otherwise healthy. Lenght of stay is typically 5 days, due to pain and lack of mobilisation.
In this study patients are randomized to either high dose (48 mg) or standard/low dose (8 mg) dexamethasone, administered preoperatively. The hypothese is that patients receiving high dose dexamethasone will experience less pain in the immediate postoperative course and receive less opioids.
The study is not placebo-controlled since the positive effects of dexamethasone 8 mg on PONV have been shown in numerous trials, and is already being administered to all patients at the clinic. It would therefore not be ethically correct to withdraw from this practise.
- Conditions
- Hip Dysplasia, Postoperative Complications
- Being tested
- Dexamethasone
- Medical subject headings
- Hip Dislocation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 48 mg | Active comparator | Dexamethasone 48 mg pre-operative, single shot injection Receives: Drug: Dexamethasone |
| Dexamethasone 8 mg | Active comparator | Dexamethasone 8 mg pre-operative, single shot injection Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Moderate to Severe Postoperative Pain
Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)
Measured: 12 hours
Secondary outcomes (10)
Lenght of Stay, PACU
Total lenght of stay in PACU
Measured: 24 hours
Lenght of Stay, Hospital
Total lenght of stay, Hospital
Measured: 1 week
Pain Scores, PACU
Differences between groups in maximal and average pain score during PACU stay. Pain scores are measured on a numeric rating scale (NRS), 0-10. 0 is no pain, 10 is worst pain imaginable.
Measured: 12 hours
Complications
Patients with complications requiring treatment the first 24 hours (PACU and ward)
Measured: 24 hours
Self Reported Postoperative Pain
Self-reported pain on a Numeric rating scale (NRS), NRS 0-10, 0 = no pain, 10= worst pain imaginable.
Reported once daily, postoperative days 0 to 4
Measured: postoperative day 0 to 4, once a day
Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4
Patients reporting PONV and/or receiving antiemetic medication on postoperative days 0 to 4
Measured: postoperative day 0 to 4, once a day
Number of Patients With Sleep Problems
Self-reported quality of sleep (days 0-4). Questionnaire. Results dichotomized to sleep problems (trouble falling asleep, frequent awakenings, no sleep) or no sleep problems.
Measured: 4 days
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness
Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire
Measured: postoperative day 0 to 4, once a day
Number of Patients Readmitted to Hospital Within 30 Days
Any readmission within 30 days
Measured: 30 days
Number of Patients With Wound Infections Within 30 Days
Any wound infections/complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start24 Apr 2017
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Julia Steinthorsdottir, Copenhagen University Hospital, Rigshospitalet
- Investigators
- kristin J Steinthorsdottir, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161938
- Sponsor's protocol ID
- DEXGANZ01
- Acronym
- DEX-GANZ
- Status last verified
- Apr 2020
- First submitted
- 17 May 2017
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinthorsdottir KJ, Awada HN, Dirks J, Sturup J, Winther NS, Kehlet H, Aasvang EK. Early postoperative recovery after peri-acetabular osteotomy: A double-blind, randomised single-centre trial of 48 vs. 8 mg dexamethasone. Eur J Anaesthesiol. 2021 Mar 1;38(Suppl 1):S41-S49. doi: 10.1097/EJA.0000000000001410.
PubMed 33399374