Effectiveness of Peri-operative Combined Use of 2 Doses of Dexamethasone With Tranexamic Acid in Lower Limb Joint Replacements- A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- C-reactive protein
研究概览
简要总结
The goal of this randomized controlled clinical trial is to investigate the effectiveness of peri operative use of 2 doses of dexamethasone with tranexamic acid in lower limb replacement, on post operative C-reactive protein (CRP), joint range of motion, fatigue, pain, hospital length of stay in male/female patients undergoing lower limb joint replacement, with pre op Hb above 10g/dL.
The main question it aims to answer The peri operative use of 2 doses of dexamethasone with tranexamic acid in lower limb replacement, decrease the post operative CRP, fatigue, pain, hospital length of stay and increase the joint range of motion.
Researcher will compare the two groups without knowing which group received either of 1 or 2 doses of Dexamethasone with TXA peri operatively.
Patients will do answer the questions mentioned in questionnaire pre operatively, at post op 1st day, at 1st week and 4th week post discharge.
详细描述
1 INTRODUCTION/BACKGROUND Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are highly effective interventions 45 for end-stage arthritis of the knee and hip. Controlling postoperative pain and nausea after total joint arthroplasty remains an important challenge. Perioperative corticosteroids are safe, facilitate earlier discharge, and improve patient recovery following unilateral total knee arthroplasty and total hip arthroplasty. Higher doses (15-20 mg of dexamethasone) are associated with further reductions in dynamic pain and PONV, and repeat dosing may further reduce LOS. It was found that neither one nor two doses of 24 mg intravenous dexamethasone demonstrated prolonged effects on overall pain or sleep quality on postoperative days 3-7 after total knee arthroplasty, also have no effect on patients satisfaction, but it reduced the opioid consumption. Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA) . Hence, it was proved that the combination of TXA and DEX has positive impacts on the usage of oxycodone and metoclopramide, postoperative range of motion, postoperative nausea and vomiting and reduces the length of hospital stay .The administration of 10 mg dexamethasone 1 h before the surgery, and repeated at 6 h postoperatively can significantly reduce the level of postoperative CRP and IL-6. There is insufficient evidence on perioperative dexamethasone in primary TJA to determine the optimal dose, number of doses, or risk of postoperative adverse events.
2. .Background of interventional procedure: Total joint arthroplasty (TKA) is viewed as one of the most successful orthopedic surgeries for most end-stage joint diseases. In recent years, the concept of enhanced recovery after surgery (ERAS) has greatly improved the speed of rehabilitation after total joint arthroplasty. Patients feel more comfortable during the perioperative period and have shorter hospital stays with the administration of steroidal administration. Dexamethasone plays an important role in ERAS due to its anti-inflammatory and pain reduction role. As, TXA can prevent the activation of plasminogen and delay fibrinolysis and reduce blood loss and the rate of blood transfusion perioperatively. Recent studies showed that dexamethasone may be administered multiple times peri operatively. A large number of studies confirmed that dexamethasone can reduce post operative pain and inflammation and shortens the length of hospital stay and combination pre operative tranexamic acid with dexamethasone reduces the limb swelling that improves the joint range of motion. There will be no risk of the interventional drug Benefits will include that the drug is cost effective, easily available, reduce the post operative complications
3. Rationale: Previous studies showed the effects of peri-operative use of single dose of dexamethasone, and there is very little data available on effects of peri-op use of multiple doses of dexamethasone. There is no study that has been conducted yet, which compared the effects of peri-op use of 1 dose of dexamethasone and tranexamic acid with 2 doses of dexamethasone and tranexamic acid, on post operative range of motion and pain during rest and weight bearing on operated limb, length of stay in hospital and C-reactive protein.
4. Study Objectives:
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The randomization assignments were placed into sequentially numbered opaque sealed envelopes, which Will be kept by a certificated research Physiotherapist. The envelope will be opened on the day of operation, and the corresponding drug and placebo will be handled by a researcher who will not involve in patient care. The patients, trial participants, anesthesiologists and data collectors will be blinded to allocation
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral or bilateral total joint replacement surgery in grade 4 osteoarthritis.
- •Patients having pre-operative hemoglobin above 10g/dL.
- •Include both genders.
- •Patients having age more than 45 years.
- •Exclusion Criteria
- •Patients having history of thromboembolic event.
- •Patients having tranexamic and steroidal allergy.
- •Patients having pre operative Hemoglobin level less than 10g/dL
- •Patients having history of clotting disorders including abnormal prothrombin time, prothrombin time test, or international normalized ratio.
排除标准
- 未提供
研究组 & 干预措施
GROUP A
GROUP A will receive 1 dose of dexamethasone (10mg) with tranexamic acid (20mg/kg), peri operatively
干预措施: 1 DOSE OF DEXAMETHASONE AND TRANEXAMIC ACID (Drug)
GROUP B
GROUP B will receive 2 doses of dexamethasone (10mg) with tranexamic acid (20mg/kg), peri operatively
干预措施: 2 DOSES OF DEXAMETHASONE AND TRANEXAMIC ACID (Drug)
结局指标
主要结局
C-reactive protein
时间窗: Will be measure pre operatively, at post operative 1st day
A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of blood. CRP is a protein that liver makes. Normally, level of c-reactive protein in blood is low. If the liver releases more CRP into bloodstream indicates inflammation in body. High levels of CRP may mean serious health condition that causes inflammation.
Post operative pain:
时间窗: Will be measure pre operatively, at post operative 1st day, at 1st week after discharge, at 4th week after discharge to the end of treatment at 1 year
Postoperative pain is an anticipated and temporary measure. Increase in surgical pain is due to newly created wounds at the skin incision site. It can be measured by numeric pain rating scale including scores 1-10, 1 represents no pain and 10 represents severe pain. It will be measured during rest as well as during weight bearing in this study.
Joint range of motion:
时间窗: Will be measure pre operatively, at post operative 1st day, at 1st week after discharge, at 4th week after discharge
It can be defined as what is achieved when a force, causes movement of a joint, measured by goniometry in which goniometer is used to measure the range of joint movement.
次要结局
- Post operative fatigue:(Will be measure pre operatively, at post operative 1st day, at 1st week after discharge, at 4th week after discharge)
- Length of hospital stay:(Will be measure at 1st week after discharge)
研究者
Zaib Un Nisa
PHYSIOTHERAPIST
Indus Hospital and Health Network
