Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
314 participants
INTERVENTIONAL
2016-04-30
2018-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
Dexamethasone
8mg (2mL) of Dexamethasone added to standard LIA mixture
LIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA-PS I-III
* 18-85 years of age, inclusive
* 50-100 kg, inclusive
* BMI 18 - 40
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Toronto Western Hopspital
Toronto, Ontario, Canada
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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UHN15-9898-A
Identifier Type: -
Identifier Source: org_study_id