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Completed

NCT Number: NCT03161938

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • planned unilateral periacetabular osteotomy
  • informed signed consent

Exclusion criteria

  • 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

Treatment and study plan

Dexamethasone

Drug

intravenous

Primary outcomes

  1. Number of Participants With Moderate to Severe Postoperative Pain

    Time frame: 12 hours

    Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)

Secondary outcomes

  1. Lenght of Stay, PACU

    Time frame: 24 hours

    Total lenght of stay in PACU

  2. Lenght of Stay, Hospital

    Time frame: 1 week

    Total lenght of stay, Hospital

  3. Pain Scores, PACU

    Time frame: 12 hours

    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.

  4. Complications

    Time frame: 24 hours

    Patients with complications requiring treatment the first 24 hours (PACU and ward)

  5. Self Reported Postoperative Pain

    Time frame: postoperative day 0 to 4, once a day

    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

  6. Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4

    Time frame: postoperative day 0 to 4, once a day

    Patients reporting PONV and/or receiving antiemetic medication on postoperative days 0 to 4

  7. Number of Patients With Sleep Problems

    Time frame: 4 days

    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.

  8. Number of Patients With Feelings of Anxiety, Unrest and/or Sadness

    Time frame: postoperative day 0 to 4, once a day

    Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire

  9. Number of Patients Readmitted to Hospital Within 30 Days

    Time frame: 30 days

    Any readmission within 30 days

  10. Number of Patients With Wound Infections Within 30 Days

    Time frame: 30 days

    Any wound infections/complications

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Periacetabular (GANZ) Osteotomy

Acronym: DEX-GANZ

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 22, 2017
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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