Total Knee ArthroplastyPhase 2/3NCT02760043
Dexamethasone in Total Knee and Total Hip Arthroplasty
A Phase 2/3 study testing Dexamethasone and LIA Combination Mixture in people with Total Knee Arthroplasty and Total Hip Arthroplasty, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty, Total Hip Arthroplasty, Osteoarthritis
- What is being tested?
- Dexamethasone and LIA Combination Mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Oct 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Chronic pain state, neuropathic pain
- Opioid dependence
- Diabetic patients will NOT be excluded except those with significant peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hopspital
Toronto, Ontario, M5T2S8
Vincent Chan, MD. FRCPC
About this study
Official title: Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
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.
Read the 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.
- Being tested
- Dexamethasone, 0.9% NaCl Placebo, LIA Combination Mixture
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Baycadron
8mg (2mL) of Dexamethasone added to standard LIA mixture
0.9% NaCl PlaceboOther
Also called Saline
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
LIA Combination MixtureDrug
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | LIA mixture with the addition of 8mg Dexamethasone. Receives: Drug: Dexamethasone; Drug: LIA Combination Mixture |
| Saline | Sham comparator | LIA mixture with the addition of 2mL of 0.9% NaCl Saline. Receives: Other: 0.9% NaCl Placebo; Drug: LIA Combination Mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
Measured: 3 days - post operative
Secondary outcomes (9)
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
- POD 3 during physiotherapy if still in hospital
Measured: 3 days - post operative
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
Measured: 3 days - post operative
Analgesic outcomes- TUG test
Timed Up and Go Test (TUG) on postoperative days 2 or 3
Measured: 3 days - post operative
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
Measured: 3 days - post operative
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
Measured: 3 days post operative
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
Measured: 3 days - post operative
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
Measured: 3 days - post operatively
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
Measured: 3 months- post operative
Medium-term self-reported functional outcome measures- LFES
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively
Measured: 3 months- post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760043
- Sponsor's protocol ID
- UHN15-9898-A
- Status last verified
- Nov 2017
- First submitted
- 14 Apr 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Undecided at this moment.
Publications
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.
PubMed 33199379El-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.
PubMed 31563881
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
- ClinicalTrials.gov ID
- NCT02760043
- Acronym / sponsor ID
- UHN15-9898-A
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone, Drug: LIA Combination MixtureLIA mixture with the addition of 8mg Dexamethasone. |
| Saline | Sham comparator | Other: 0.9% NaCl Placebo, Drug: LIA Combination MixtureLIA mixture with the addition of 2mL of 0.9% NaCl Saline. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Baycadron8mg (2mL) of Dexamethasone added to standard LIA mixture | Drug | Dexamethasone |
| 0.9% NaCl PlaceboAlso: Saline2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture | Other | Saline |
| LIA Combination Mixture150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine | Drug | Dexamethasone, Saline |
Primary outcome
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
Time frame: 3 days - post operative
9 secondary outcomes
Analgesic outcomes- pain
Time frame: 3 days - post operative
Analgesic outcomes- opiate consumption
Time frame: 3 days - post operative
Analgesic outcomes- TUG test
Time frame: 3 days - post operative
Analgesic outcomes- Drug side-effects
Time frame: 3 days - post operative
Short-term physical and performance-based functional outcome measures- in hospital complications
Time frame: 3 days post operative
Short-term physical and performance-based functional outcome measures- length of stay
Time frame: 3 days - post operative
Short-term physical and performance-based functional outcome measures- discharge
Time frame: 3 days - post operatively
Medium-term self-reported functional outcome measures- WOMAC
Time frame: 3 months- post operative
Medium-term self-reported functional outcome measures- LFES
Time frame: 3 months- post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Derived from this study: PubMed 33199379El-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.
- Derived from this study: PubMed 31563881El-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.
- Individual participant dataSharing planned: Undecided. Undecided at this moment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone and LIA Combination Mixture in people with Total Knee Arthroplasty and Total Hip Arthroplasty, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Chan, MD (4166035118, vincent.chan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively (time frame: 3 days - post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760043, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.