Dexamethasone in Total Knee and Total Hip Arthroplasty
Does the Addition of Dexamethasone to a Local Infiltration Analgesia Mixture Improve Functional Outcomes Following Total Joint Arthroplasty?
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M5T2S8
- 募集
- Toronto Western Hopspital
-
主任研究者：
- Vincent Chan, MD. FRCPC
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
|
8mg (2mL) of Dexamethasone added to standard LIA mixture
他の名前：
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
|
|
偽コンパレータ：Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
|
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
時間枠：3 days - post operative
|
3 days - post operative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Analgesic outcomes- pain
時間枠：3 days - post operative
|
Pain scores assessed with an 11 point verbal numeric rating scale (NRS) at the following time points:
g. POD 3 during physiotherapy if still in hospital |
3 days - post operative
|
|
Analgesic outcomes- opiate consumption
時間枠：3 days - post operative
|
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
|
|
Analgesic outcomes- TUG test
時間枠：3 days - post operative
|
Timed Up and Go Test (TUG) on postoperative days 2 or 3
|
3 days - post operative
|
|
Analgesic outcomes- Drug side-effects
時間枠：3 days - post operative
|
Incidence of opioid-related side effects:
|
3 days - post operative
|
|
Short-term physical and performance-based functional outcome measures- in hospital complications
時間枠：3 days post operative
|
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
|
|
Short-term physical and performance-based functional outcome measures- length of stay
時間枠：3 days - post operative
|
Hospital length of stay- the total number of days the patient stayed in hospital to recover from elective surgery
|
3 days - post operative
|
|
Short-term physical and performance-based functional outcome measures- discharge
時間枠：3 days - post operatively
|
Discharge destination- determination of location for which the patient was discharged; either to home or to rehabilitation centre
|
3 days - post operatively
|
|
Medium-term self-reported functional outcome measures- WOMAC
時間枠：3 months- post operative
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
|
3 months- post operative
|
|
Medium-term self-reported functional outcome measures- LFES
時間枠：3 months- post operative
|
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively
|
3 months- post operative
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。