NCT02760043

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
314

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

2.5 years

First QC Date

April 14, 2016

Last Update Submit

November 21, 2017

Conditions

Total Knee ArthroplastyTotal Hip ArthroplastyOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively

    3 days - post operative

Secondary Outcomes (9)

  • Analgesic outcomes- pain

    3 days - post operative

  • Analgesic outcomes- opiate consumption

    3 days - post operative

  • Analgesic outcomes- TUG test

    3 days - post operative

  • Analgesic outcomes- Drug side-effects

    3 days - post operative

  • Short-term physical and performance-based functional outcome measures- in hospital complications

    3 days post operative

  • +4 more secondary outcomes

Study Arms (2)

Dexamethasone

EXPERIMENTAL

LIA mixture with the addition of 8mg Dexamethasone.

Drug: DexamethasoneDrug: LIA Combination Mixture

Saline

SHAM COMPARATOR

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

Other: 0.9% NaCl PlaceboDrug: LIA Combination Mixture

Interventions

DexamethasoneDRUG

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

Also known as: Baycadron
Dexamethasone
0.9% NaCl PlaceboOTHER

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

Also known as: Saline
Saline
LIA Combination MixtureDRUG

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

DexamethasoneSaline

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

Related Publications (2)

  • El-Boghdadly K, Short AJ, Gandhi R, Chan V. Addition of dexamethasone to local infiltration analgesia in elective total knee arthroplasty: double-blind, randomized control trial. Reg Anesth Pain Med. 2021 Feb;46(2):130-136. doi: 10.1136/rapm-2020-102079. Epub 2020 Nov 16.

    PMID: 33199379DERIVED

  • El-Boghdadly K, Short AJ, Gandhi R, Chan VWS. Addition of dexamethasone to local infiltration analgesia in elective total hip arthroplasty: a double-blind, randomized control trial. Reg Anesth Pain Med. 2019 Sep 27:rapm-2019-100873. doi: 10.1136/rapm-2019-100873. Online ahead of print.

    PMID: 31563881DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

DexamethasoneCalcium DobesilateSodium Chloride

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Vincent Chan, MD

CONTACT

4166035118vincent.chan@uhn.ca

Kariem El-Boghdadly, MD

CONTACT

4166035800elboghdadly@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

May 3, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

CA(1)