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Dexamethasone in Total Knee and Total Hip Arthroplasty

Primary Purpose

Total Knee Arthroplasty, Total Hip Arthroplasty, Osteoarthritis

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone
0.9% NaCl Placebo
LIA Combination Mixture
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Total Knee Arthroplasty

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western HopspitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dexamethasone

Saline

Arm Description

LIA mixture with the addition of 8mg Dexamethasone.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Analgesic outcomes- pain
Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points: The post-anesthetic care unit (PACU) Postoperative day (POD) 1 at rest between 8-10 AM POD1 during physiotherapy POD 2 at rest between 8 -10 AM POD 2 during physiotherapy g. POD 3 during physiotherapy if still in hospital
Analgesic outcomes- opiate consumption
Cumulative systemic opioid consumption measured as oral morphine mg equivalents on POD 1, POD2, and, if still in hospital, POD 3, as well as the proportion of patients who required "rescue" intravenous patient controlled analgesia (IV PCA) anytime in the postoperative period
Analgesic outcomes- TUG test
Timed Up and Go Test (TUG) on postoperative days 2 or 3
Analgesic outcomes- Drug side-effects
Incidence of opioid-related side effects: Nausea and vomiting requiring treatment with anti-emetic Pruritus requiring treatment with antihistamines Sedation requiring treatment with opioid antagonist
Short-term physical and performance-based functional outcome measures- in hospital complications
In-hospital complications- Any outcomes such as MI, surgical site infection, neurological complications, etc. that may have occurred during the hospital stay
Short-term physical and performance-based functional outcome measures- length of stay
Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery
Short-term physical and performance-based functional outcome measures- discharge
Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre
Medium-term self-reported functional outcome measures- WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
Medium-term self-reported functional outcome measures- LFES
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively

Full Information

First Posted
April 14, 2016
Last Updated
November 21, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02760043
Brief Title
Dexamethasone in Total Knee and Total Hip Arthroplasty
Official Title
Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The addition of dexamethasone to an local infiltration analgesia (LIA) mixture for postoperative analgesia following total knee arthroplasty (TKA) has a limited evidence base. Although there is increasing support in the literature for its use in peripheral nerve blockade, there have only been a handful of studies assessing its applicability in periarticular LIA. Moreover, the evidence from peripheral nerve blocks suggests that one of the key benefits of dexamethasone is a prolongation of nerve blockade. Additionally, dexamethasone has been shown to prolong the local analgesic effect of bupivacaine microcapsules. With respect to total hip arthroplasty (THA), there have only been two small studies that included corticosteroids in the LIA mixture; there was analgesic benefit and better early rehabilitation outcomes when compared to placebo. However, there is limited high-quality evidence for either THA or TKA demonstrating an improvement in functional outcomes when dexamethasone is used in an LIA mixture. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Total Hip Arthroplasty, Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
314 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
LIA mixture with the addition of 8mg Dexamethasone.
Arm Title
Saline
Arm Type
Sham Comparator
Arm Description
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Baycadron
Intervention Description
8mg (2mL) of Dexamethasone added to standard LIA mixture
Intervention Type
Other
Intervention Name(s)
0.9% NaCl Placebo
Other Intervention Name(s)
Saline
Intervention Description
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
Intervention Type
Drug
Intervention Name(s)
LIA Combination Mixture
Intervention Description
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
Primary Outcome Measure Information:
Title
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
Time Frame
3 days - post operative
Secondary Outcome Measure Information:
Title
Analgesic outcomes- pain
Description
Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points: The post-anesthetic care unit (PACU) Postoperative day (POD) 1 at rest between 8-10 AM POD1 during physiotherapy POD 2 at rest between 8 -10 AM POD 2 during physiotherapy g. POD 3 during physiotherapy if still in hospital
Time Frame
3 days - post operative
Title
Analgesic outcomes- opiate consumption
Description
Cumulative systemic opioid consumption measured as oral morphine mg equivalents on POD 1, POD2, and, if still in hospital, POD 3, as well as the proportion of patients who required "rescue" intravenous patient controlled analgesia (IV PCA) anytime in the postoperative period
Time Frame
3 days - post operative
Title
Analgesic outcomes- TUG test
Description
Timed Up and Go Test (TUG) on postoperative days 2 or 3
Time Frame
3 days - post operative
Title
Analgesic outcomes- Drug side-effects
Description
Incidence of opioid-related side effects: Nausea and vomiting requiring treatment with anti-emetic Pruritus requiring treatment with antihistamines Sedation requiring treatment with opioid antagonist
Time Frame
3 days - post operative
Title
Short-term physical and performance-based functional outcome measures- in hospital complications
Description
In-hospital complications- Any outcomes such as MI, surgical site infection, neurological complications, etc. that may have occurred during the hospital stay
Time Frame
3 days post operative
Title
Short-term physical and performance-based functional outcome measures- length of stay
Description
Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery
Time Frame
3 days - post operative
Title
Short-term physical and performance-based functional outcome measures- discharge
Description
Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre
Time Frame
3 days - post operatively
Title
Medium-term self-reported functional outcome measures- WOMAC
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
Time Frame
3 months- post operative
Title
Medium-term self-reported functional outcome measures- LFES
Description
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively
Time Frame
3 months- post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Chan, MD
Phone
4166035118
Email
vincent.chan@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kariem El-Boghdadly, MD
Phone
4166035800
Email
elboghdadly@gmail.com
Facility Information:
Facility Name
Toronto Western Hopspital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Chan, MD. FRCPC

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided at this moment.
Citations:
PubMed Identifier
33199379
Citation
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.
Results Reference
derived
PubMed Identifier
31563881
Citation
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.
Results Reference
derived

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Dexamethasone in Total Knee and Total Hip Arthroplasty

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