High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase (DEX-GANZ)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Hip Dysplasia
• Intervention / Treatment: Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone 48 mg; Dexamethasone 48 mg pre-operative, single shot injection	Drug: Dexamethasone; intravenous
Active Comparator: Dexamethasone 8 mg; Dexamethasone 8 mg pre-operative, single shot injection	Drug: Dexamethasone; intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Moderate to Severe Postoperative Pain	Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of Stay, PACU	Total lenght of stay in PACU	24 hours
Lenght of Stay, Hospital	Total lenght of stay, Hospital	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.	12 hours
Complications	Patients with complications requiring treatment the first 24 hours (PACU and ward)	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	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	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.	4 days
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness	Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire	postoperative day 0 to 4, once a day
Number of Patients Readmitted to Hospital Within 30 Days	Any readmission within 30 days	30 days
Number of Patients With Wound Infections Within 30 Days	Any wound infections/complications	30 days

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: kristin J Steinthorsdottir, MD, Rigshospitalet, Denmark

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Postoperative Complications; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: DEXGANZ01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No