Recruiting
Phase 2
Phase 3

Dexamethasone

Sponsor:

University Health Network, Toronto

Code:

NCT02760043

Conditions

Total Knee Arthroplasty

Total Hip Arthroplasty

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

0.9% NaCl Placebo

LIA Combination Mixture

Study Details

Brief summary:

This study will evaluate if the addition of dexamethasone to a local infiltration analgesia mixture will improve functional outcomes following total hip and knee arthroplasty.

Conditions

Total Knee Arthroplasty

Total Hip Arthroplasty

Osteoarthritis

Study ID

NCT02760043

Start date

Apr, 2016

Status verified date

Nov, 2017

Completion date

Oct, 2018

Anticipated

Primary completion date

Oct, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing elective, primary, unilateral total hip or knee arthroplasty under spinal anesthesia
  • ASA-PS I-III
  • 18-85 years of age, inclusive
  • 50-100 kg, inclusive
  • BMI 18 - 40

Exclusion Criteria:

  • Revision hip/knee arthroplasty
  • Bilateral hip/knee arthroplasty
  • Inability or refusal to provide informed consent
  • Any contraindication to spinal anesthesia (e.g., bleeding diathesis, infection, neuropathy)
  • Allergy to local anesthesia, ketorolac or dexamethasone
  • Allergy to opioids
  • Chronic pain state, neuropathic pain
  • Opioid dependence
  • Diabetic patients will NOT be excluded except those with significant peripheral neuropathy

Study Design

Enrollment

314 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Dexamethasone

LIA mixture with the addition of 8mg Dexamethasone.

sham comparator: Saline

LIA mixture with the addition of 2mL of 0.9% NaCl Saline.

Interventions

Dexamethasone

8mg (2mL) of Dexamethasone added to standard LIA mixture

0.9% NaCl Placebo

2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture

LIA Combination Mixture

150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine

Primary outcome measure

  • Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively [ Time Frame: 3 days - post operative ]

Central Contacts and Locations

Central contacts

Vincent Chan, MD

4166035118vincent.chan@uhn.ca

Kariem El-Boghdadly, MD

4166035800elboghdadly@gmail.com

Locations

Toronto Western Hopspital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Principal Investigator:

Vincent Chan, MD. FRCPC

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 24, 2017

Last verified

Nov, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2017-11-24.