NCT02767882

Brief Summary

The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problem despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens. Dexamethasone is glucocorticoid which is associated with anti-inflammatory response. It is well known to have prophylaxis effect for post-operative nausea and vomiting. Perioperative single dose of systemic dexamethasone have shown to be useful for reduction in pain and cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after surgical procedures. However, this dose recommendation is not surgery specific. It is essential to have more RCTs evaluating the optimal dose of steroid for pain management after hip and knee surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

May 6, 2016

Last Update Submit

May 17, 2022

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • pain score

    Pain will be measured using numerical rating scale from 0 to 10 with 0 is no pain and 10 is the worst pain

    at postoperative day 1

Secondary Outcomes (1)

  • quality of recovery

    at postoperative day 1

Study Arms (3)

Group D1

ACTIVE COMPARATOR

Patients from group D will be given a bolus injection of 2 ml saline with 2 ml dexamethasone (4mg/ml) before skin incision.

Drug: Dexamethasone

Group D2

EXPERIMENTAL

4ml bolus injection of dexamethasone (4mg/ml) will be given intravenously prior to incision.

Drug: Dexamethasone

Group C

PLACEBO COMPARATOR

4ml bolus injection of 0.9% saline will be given intravenously prior to incision

Drug: Saline

Interventions

DexamethasoneDRUG

Bolus injection of different dose of dexamethasone will be given intravenously prior to incision.

Group D1Group D2
SalineDRUG

Bolus injection of 4ml 0.9% saline will be given intravenously prior to incision.

Group C

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Age 18-80 years old
  • Scheduled for elective primary unilateral total knee replacement
  • Chinese patients
  • Able to speak and understand Cantonese
  • Able to provide informed oral and written consent

You may not qualify if:

  • Revision total knee replacement
  • Single stage bilateral total knee replacement
  • Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
  • History of chronic pain other than chronic knee pain
  • History of insulin dependent diabetic mellitus, but not diabetic mellitus on oral hyperglycaemic agents
  • History of hepatitis B or C carrier
  • History of peptic ulcer
  • Hx of tuberculosis
  • History of immunosuppression
  • Daily use of glucocorticoids
  • Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
  • History of severe heart disease (NYHA 2)
  • Alcohol or drug abuse
  • Impaired renal function, defined as preoperative serum creatinine level over 120micromol/L
  • Pre-existing neurological or muscular disorders
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Chan TCW, Cheung CW, Wong SSC, Chung AYF, Irwin MG, Chan PK, Fu H, Yan CH, Chiu KY. Preoperative dexamethasone for pain relief after total knee arthroplasty: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1157-1167. doi: 10.1097/EJA.0000000000001372.

    PMID: 33105245DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

DexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Chi Wai Cheung, MD, MBBS

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

May 1, 2016

Primary Completion

January 31, 2019

Study Completion

December 31, 2020

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)