- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02760043
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?
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
-
-
Ontario
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Toronto, Ontario, 캐나다, M5T2S8
- 모병
- Toronto Western Hopspital
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수석 연구원:
- Vincent Chan, MD. FRCPC
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Dexamethasone
LIA mixture with the addition of 8mg Dexamethasone.
|
8mg (2mL) of Dexamethasone added to standard LIA mixture
다른 이름들:
150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
|
|
가짜 비교기: Saline
LIA mixture with the addition of 2mL of 0.9% NaCl Saline.
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150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Cumulative systemic opioid consumption measured as oral morphine mg equivalents at 24 hours postoperatively
기간: 3 days - post operative
|
3 days - post operative
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Analgesic outcomes- pain
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
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Short-term physical and performance-based functional outcome measures- length of stay
기간: 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
기간: 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
|
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Medium-term self-reported functional outcome measures- WOMAC
기간: 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
기간: 3 months- post operative
|
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively
|
3 months- post operative
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UHN15-9898-A
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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