Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
研究概览
简要总结
The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.
详细描述
This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures. The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery). The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators. The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.
排除标准
- •Patients will be excluded from participation if they have one or more of the following conditions:
- •Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count > 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source
- •End-stage renal disease
- •A history of diabetic neuropathy
- •A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
- •Leukopenia (white blood cell count < 2,000/ul)
- •Thrombocytopenia (platelet count < 100,000/ul)
- •Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
- •A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
- •Pregnant or breastfeeding
研究组 & 干预措施
Anakinra
Two subcutaneous injections of anakinra (IL-1ra) were given, the first one hour prior to surgery and the second 24 hours after surgery.
干预措施: Anakinra (Drug)
Saline injection
Two subcutaneous injections of normal saline (same volume as the anakinra group injection) were given, the first one hour prior to surgery and the second 24 hours after surgery.
干预措施: Normal Saline (Other)
结局指标
主要结局
Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.
时间窗: Up to 72 hours following surgery
Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1
次要结局
- Count of Participants With Venous Thrombosis After Surgery During Hospitalization(Up to 72 hours following surgery plus 3 weeks follow-up)
- Assess Rates of Wound Dehiscence(Up to 72 hours following surgery plus 3 weeks follow-up)
- Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery(Up to 72 hours following surgery)
- Post-operative Pain Intensity(Up to 72 hours following surgery)
- Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital(Up to 72 hours following surgery plus 3 weeks follow-up)
- Total Length of Hospital Stay(Up to approximately 5 days maximum (admittance to discharge))
研究者
Gary Peltz
Professor of Anesthesiology, Perioperative and Pain Medicine
Stanford University