DEXRAR: DEXamethasone in Revision ARthroplasty

Pain, Postoperative Clinical Trial

— DEXRAR  

Official title:

DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02884180
• Other study ID #: SM1-DHAG-2016
• Secondary ID: 2016-002769-72
• Status: Recruiting
• Phase: Phase 4
• Start date: May 31, 2017
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: Naestved Hospital
• Contact: Daniel Hägi-Pedersen, MD
• Phone: +4556514792
• Email: dhag[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial

Trial acronym: DEXRAR

Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy.

Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia

Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v.

Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients.

Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).

• Age > 18

• American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3.

• Body mass index (BMI) > 18 and < 45

• Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (HCG) pregnancy test

• Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.

Exclusion Criteria:

• Patients who cannot cooperate with the trial.

• Concomitant participation in another trial involving medication

• Patients who cannot understand or speak Danish.

• Patients with allergy to medicines used in the trial.

• Patients with daily use of methadone.

• Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)

• Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Dexamethasone
A dose of 24 mg dexamethasone given after start of anaesthesia
• Saline isotonic
A dose of 6 ml of isotonic saline given after start of anaesthesia

Locations

Country	Name	City	State
Denmark	Næstved Hospital	Næstved	Region Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Hägi-Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of sleep (Verbal rating scale)	Level of quality of sleep. Verbal rating scale: very bad, fairly bad, fairly good, very good	24 hours postoperatively
Other	Blood sugar level at 6 hours postoperatively	Level of blood sugar af 6 hours postoperatively in mmol/L	6 hours postoperatively
Other	Blood sugar level at 24 hours postoperatively	Level of blood sugar at 24 hours postoperatively in mmol/L	24 hours postoperatively
Other	Number of patients with need for antibiotic treatment and/or reoperation within 90 days	Number of patients with need for antibiotic treatment and/or reoperation within 90 days after surgery	0 - 90 days postoperatively
Other	Serious adverse events	Serious adverse events (SAE), including death, within 90 days after surgery defined as SAE (according to International Conference on Harmonization (ICH) - good clinical practice (GCP) - guidelines) except "prolongation of hospitalisation"	0-90 days postoperatively
Other	Days alive and outside hospital within 90 days after surgery	Days alive and outside hospital within 90 days after surgery	0-90 days postoperatively
Other	Quality of live, function	Oxford Knee Score (OKS) before surgery	Before surgery
Other	Quality of live, function	Oxford Knee Score (OKS) 6 month after surgery	6 month postoperatively
Other	Quality of live, function	Oxford Knee Score (OKS) 12 month after surgery	12 month postoperatively
Other	Quality of live, function	EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) before surgery	Before surgery
Other	Quality of live, function	EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 6 month after surgery	6 month postoperatively
Other	Quality of live, function	EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 12 month after surgery	12 month postoperatively
Other	Quality of live, function	Short Form 36 (SF-36) before surgery	Before surgery
Other	Quality of live, function	Short Form 36 (SF-36) 6 month after surgery	6 month postoperatively
Other	Quality of live, function	Short Form 36 (SF-36) 12 month after surgery	12 month postoperatively
Primary	Morphine consumption the first 24 hours postoperatively	Total need for morphine for the first 24 hours postoperatively administered as both patient controlled analgesia (PCA) and supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively	0-24 hours postoperatively
Secondary	Pain during movement at 6 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100	6 hours postoperatively
Secondary	Pain during movement at 24 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) with active 45 degrees flexion of the knee at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100	24 hours postoperatively
Secondary	Pain at rest at 6 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100	6 hours postoperatively
Secondary	Pain at rest at 24 hours postoperatively (visual analogue scale)	Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100	24 hours postoperatively
Secondary	Timed up and go test	Time in seconds, for standing up from a chair, walking 3 meters, turning around, walking back to the chair and sit down again	24 hours postoperatively
Secondary	Adverse events	Number of patients with one or more adverse events in the intervention period (0-24 hours)	0 - 24 hours postoperatively
Secondary	Nausea at 6 hours postoperatively (Verbal rating scale)	Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	6 hours postoperatively
Secondary	Nausea at 24 hours postoperatively (Verbal rating scale)	Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	24 hours postoperatively
Secondary	Vomiting the first 24 hours postoperatively	Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively	0-24 hours postoperatively
Secondary	Dizziness at 6 hours postoperatively (Verbal rating scale)	Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	6 hours postoperatively
Secondary	Dizziness at 24 hours postoperatively (Verbal rating scale)	Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	24 hours postoperatively
Secondary	Sedation at 6 hours postoperatively (Verbal rating scale)	Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	6 hours postoperatively
Secondary	Sedation at 24 hours postoperatively (Verbal rating scale)	Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe	24 hours postoperatively
Secondary	Anti-emetic treatment the first 24 hours postoperatively	Consumption of ondansetron in the period 0-24 hours postoperatively	0-24 hours postoperatively