Stopping Fish Oil Supplementation Prior to Total Hip Replacement a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Total perioperative blood loss
研究概览
简要总结
The purpose of this study is to determine if continuing fish oil supplementation leads to higher blood loss in patients undergoing total hip arthroplasty (THA). Another purpose is to determine if patients on fish oil have less pain after THA. Fish oil (Omega-3 fatty acid) is commonly used by patients as a natural anti-inflammatory to decrease joint pain from arthritis. Supplements, including fish oil, are typically stopped 1-2 weeks prior to surgery as there is an increased risk of perioperative bleeding. However, there are current methods in joint replacement surgery that decrease the risk of perioperative bleeding. With the risk of excessive bleeding being minimized, fish oil may not need to be stopped prior to surgery and could be continued immediately after surgery. The anti-inflammatory effect of fish oil may also help decrease pain after surgery.
详细描述
Introduction/Purpose Fish oil (Omega-3 fatty acid) is commonly used by patients as a natural anti-inflammatory to decrease joint pain from arthritis. Furthermore, fish oil has been found to decrease the risk of coronary artery disease, decrease mild hypertension, prevent cardiac arrhythmias and decrease blood triglyceride levels. Supplements, including fish oil, are typically stopped 1-2 weeks prior to surgery as there is an increased risk of perioperative bleeding. With modern blood management techniques in joint replacement surgery, including the use of tranexamic acid, the risk of perioperative bleeding may be minimized. With the risk being minimized fish oil may not need to be stopped prior to surgery and could be continued immediately after surgery. The anti-inflammatory effect of fish oil in the perioperative period may aid in post-operative pain management. The purpose of this study is to determine if continuing fish oil supplementation leads to higher blood loss in patients undergoing unilateral total hip arthroplasty (THA). A secondary analysis is to determine if patients on fish oil have less pain after THA.
Objectives
Primary Outcome Measures:
• Calculated total perioperative blood loss milliliters (mL) using Bourke's, Gross', Camarasa's, and Lopez-Picado's formula based on post-operative (PO) D5 Hemoglobin and Hematocrit
Secondary Outcomes Measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ≥ 18 years old
- •Primary total hip arthroplasty
- •Diagnosis of osteoarthritis
- •Able to consume fish oil
- •Medically cleared for surgery
- •Plan for unilateral total hip arthroplasty
- •Able to consent to surgery and study participation
排除标准
- •Unable to consent for study participation
- •Unable to participate in preoperative testing
- •History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- •Patient reports of easy bruising
- •Revision total hip replacement
- •Indication for surgery other than osteoarthritis
- •History of surgical wound complication on involved extremity
- •Allergy to fish oil
- •Allergy to Aspirin
- •Patients on Coumadin, Eliquis, Xarelto or other anticoagulants (excluding NSAIDs)
- •Outpatient total hip replacement
- •Bilateral total hip replacement
- •Coagulopathy
结局指标
主要结局
Total perioperative blood loss
时间窗: Post-operative day 5
Calculated total perioperative blood loss (mL) using Bourke's, Gross', Camarasa's, and Lopez-Picado's formula based on Post Operative Day 5 (POD5) Hemoglobin and Hematocrit
次要结局
- Post-operative day 1 Hematocrit(Post-operative day 1)
- Post-operative day 1 Hemoglobin(Post-operative day 1)
研究者
Jeffrey L Stimac MD
Principal Investigator
Norton Healthcare