Dexamethasone in Total Knee and Total Hip Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02760043
• Other study ID #: UHN15-9898-A
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 14, 2016
• Last updated: November 21, 2017
• Start date: April 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2017
• Source: University Health Network, Toronto
• Contact: Vincent Chan, MD
• Phone: 4166035118
• Email: vincent.chan[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 314
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Total Hip Arthroplasty
• Total Knee Arthroplasty

Intervention

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

Other:
• 0.9% NaCl Placebo
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture

Drug:
• LIA Combination Mixture
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine

Locations

Country	Name	City	State
Canada	Toronto Western Hopspital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively		3 days - post operative
Secondary	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	3 days - post operative
Secondary	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	3 days - post operative
Secondary	Analgesic outcomes- TUG test	Timed Up and Go Test (TUG) on postoperative days 2 or 3	3 days - post operative
Secondary	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	3 days - post operative
Secondary	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	3 days post operative
Secondary	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	3 days - post operative
Secondary	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	3 days - post operatively
Secondary	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	3 months- post operative
Secondary	Medium-term self-reported functional outcome measures- LFES	Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively	3 months- post operative