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DEXRAR: DEXamethasone in Revision ARthroplasty (DEXRAR)

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dexamethasone
Saline isotonic
Sponsored by
Daniel Hägi-Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Dexamethasone, Arthroplasty, Replacement, Knee, Revision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Næstved HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment A

Treatment B

Arm Description

Dexamethasone 24 mg i.v. after start of anaesthesia

Saline isotonic i.v. after start of anaesthesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
Adverse events
Number of patients with one or more adverse events in the intervention period (0-24 hours)
Nausea at 6 hours postoperatively (Verbal rating scale)
Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Nausea at 24 hours postoperatively (Verbal rating scale)
Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Vomiting the first 24 hours postoperatively
Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively
Dizziness at 6 hours postoperatively (Verbal rating scale)
Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Dizziness at 24 hours postoperatively (Verbal rating scale)
Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Sedation at 6 hours postoperatively (Verbal rating scale)
Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Sedation at 24 hours postoperatively (Verbal rating scale)
Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Anti-emetic treatment the first 24 hours postoperatively
Consumption of ondansetron in the period 0-24 hours postoperatively

Full Information

First Posted
August 25, 2016
Last Updated
May 31, 2023
Sponsor
Daniel Hägi-Pedersen
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1. Study Identification

Unique Protocol Identification Number
NCT02884180
Brief Title
DEXRAR: DEXamethasone in Revision ARthroplasty
Acronym
DEXRAR
Official Title
DEXRAR: DEXamethasone in Revision ARthroplasty: A Randomised, Blinded, 2-group Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Hägi-Pedersen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Dexamethasone, Arthroplasty, Replacement, Knee, Revision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
Dexamethasone 24 mg i.v. after start of anaesthesia
Arm Title
Treatment B
Arm Type
Placebo Comparator
Arm Description
Saline isotonic i.v. after start of anaesthesia
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
A dose of 24 mg dexamethasone given after start of anaesthesia
Intervention Type
Drug
Intervention Name(s)
Saline isotonic
Intervention Description
A dose of 6 ml of isotonic saline given after start of anaesthesia
Primary Outcome Measure Information:
Title
Morphine consumption the first 24 hours postoperatively
Description
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
Time Frame
0-24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain during movement at 6 hours postoperatively (visual analogue scale)
Description
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
Time Frame
6 hours postoperatively
Title
Pain during movement at 24 hours postoperatively (visual analogue scale)
Description
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
Time Frame
24 hours postoperatively
Title
Pain at rest at 6 hours postoperatively (visual analogue scale)
Description
Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100
Time Frame
6 hours postoperatively
Title
Pain at rest at 24 hours postoperatively (visual analogue scale)
Description
Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100
Time Frame
24 hours postoperatively
Title
Timed up and go test
Description
Time in seconds, for standing up from a chair, walking 3 meters, turning around, walking back to the chair and sit down again
Time Frame
24 hours postoperatively
Title
Adverse events
Description
Number of patients with one or more adverse events in the intervention period (0-24 hours)
Time Frame
0 - 24 hours postoperatively
Title
Nausea at 6 hours postoperatively (Verbal rating scale)
Description
Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Time Frame
6 hours postoperatively
Title
Nausea at 24 hours postoperatively (Verbal rating scale)
Description
Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Time Frame
24 hours postoperatively
Title
Vomiting the first 24 hours postoperatively
Description
Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively
Time Frame
0-24 hours postoperatively
Title
Dizziness at 6 hours postoperatively (Verbal rating scale)
Description
Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Time Frame
6 hours postoperatively
Title
Dizziness at 24 hours postoperatively (Verbal rating scale)
Description
Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Time Frame
24 hours postoperatively
Title
Sedation at 6 hours postoperatively (Verbal rating scale)
Description
Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Time Frame
6 hours postoperatively
Title
Sedation at 24 hours postoperatively (Verbal rating scale)
Description
Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe
Time Frame
24 hours postoperatively
Title
Anti-emetic treatment the first 24 hours postoperatively
Description
Consumption of ondansetron in the period 0-24 hours postoperatively
Time Frame
0-24 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Quality of sleep (Verbal rating scale)
Description
Level of quality of sleep. Verbal rating scale: very bad, fairly bad, fairly good, very good
Time Frame
24 hours postoperatively
Title
Blood sugar level at 6 hours postoperatively
Description
Level of blood sugar af 6 hours postoperatively in mmol/L
Time Frame
6 hours postoperatively
Title
Blood sugar level at 24 hours postoperatively
Description
Level of blood sugar at 24 hours postoperatively in mmol/L
Time Frame
24 hours postoperatively
Title
Number of patients with need for antibiotic treatment and/or reoperation within 90 days
Description
Number of patients with need for antibiotic treatment and/or reoperation within 90 days after surgery
Time Frame
0 - 90 days postoperatively
Title
Serious adverse events
Description
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"
Time Frame
0-90 days postoperatively
Title
Days alive and outside hospital within 90 days after surgery
Description
Days alive and outside hospital within 90 days after surgery
Time Frame
0-90 days postoperatively
Title
Quality of live, function
Description
Oxford Knee Score (OKS) before surgery
Time Frame
Before surgery
Title
Quality of live, function
Description
Oxford Knee Score (OKS) 6 month after surgery
Time Frame
6 month postoperatively
Title
Quality of live, function
Description
Oxford Knee Score (OKS) 12 month after surgery
Time Frame
12 month postoperatively
Title
Quality of live, function
Description
EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) before surgery
Time Frame
Before surgery
Title
Quality of live, function
Description
EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 6 month after surgery
Time Frame
6 month postoperatively
Title
Quality of live, function
Description
EuroQol five dimensions 5 point Lipert scale (EQ-5D-5L) 12 month after surgery
Time Frame
12 month postoperatively
Title
Quality of live, function
Description
Short Form 36 (SF-36) before surgery
Time Frame
Before surgery
Title
Quality of live, function
Description
Short Form 36 (SF-36) 6 month after surgery
Time Frame
6 month postoperatively
Title
Quality of live, function
Description
Short Form 36 (SF-36) 12 month after surgery
Time Frame
12 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Hägi-Pedersen, MD
Phone
+4556514792
Email
dhag@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hägi-Pedersen, MD
Organizational Affiliation
Department of Anaesthesiology, Næstved Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Næstved Hospital
City
Næstved
State/Province
Region Zealand
ZIP/Postal Code
4700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Hägi-Pedersen, MD
Phone
+4556514792
Email
dhag@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Daniel Hägi-Pedersen, MD

12. IPD Sharing Statement

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DEXRAR: DEXamethasone in Revision ARthroplasty

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