Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

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.

Inclusion Criteria:

-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.

Exclusion Criteria:

Patients will be excluded from participation if they have one or more of the following
conditions:

1. 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

2. End-stage renal disease

3. A history of diabetic neuropathy

4. A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the
cervix within the previous 5 years

5. Leukopenia (white blood cell count < 2,000/ul)

6. Thrombocytopenia (platelet count < 100,000/ul)

7. Abnormal liver function test result (aspartate aminotransferase or alanine
aminotransferase level ≥1.5-fold the upper limit of normal)

8. A history or infection with tuberculosis, hepatitis B, hepatitis C, or human
immunodeficiency virus

9. Pregnant or breastfeeding